Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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Paclitaxel for Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer Panitumumab and Gemcitabine in Relapsed Ovarian Cancer Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer Saracatinib and Paclitaxel in Platinum-resistant Ovarian Cancer Carboplatin/Pralatrexate in Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer Irinotecan and Bevacizumab for Recurrent Ovarian Cancer A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer The Activity of TroVax® Versus Placebo in Relapsed Asymptomatic Ovarian Cancer Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer Phase 1 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer Search for Predictors of Therapeutic Response in Ovarian Carcinoma Vitamin D for Women at Increased Risk of Developing Ovarian, Fallopian, or Primary Peritoneal Cancer Accelerating Gastrointestinal Recovery BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer A Study LY2228820 for Recurrent Ovarian Cancer CRLX101 in Combination With Bevacizumab for Recurrent Ovarian/Tubal/Peritoneal Cancer Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer (SUNNY) A Study of Long-Term Responders on Olaparib Study of Safety & Biological Activity of IP GEN-1 With Neoadjuvant Chemo in Ovarian Cancer Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients Flaxseed as Maintenance Therapy for Ovarian Cancer Patients in Remission GANNET53: Ganetespib in Metastatic, p53-mutant, Platinum-resistant Ovarian Cancer Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinosis in Chemosensitive Patients Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study Pembrolizumab Combined With PLD For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Trial of Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery The Treatment Preferences of Women Diagnosed With Ovarian Cancer BEACON – ABC in Recurrent Platinum Resistant HGSOC Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma A Trial Evaluating TG4050 in Ovarian Carcinoma. Japan Phase 2 Study of Niraparib in Patients With Advanced, Relapsed Ovarian Cancer A Study of Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With a Safety Run-in of a Dose-Dense Regimen (innovaTV 208) A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission Biomarkers in Patients With Previously Untreated Invasive Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial) Structural and Functional Imaging and Cognitive Functions in Ovarian Cancer A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer A Study of Carboplatin, PLD and Everolimus in Certain Gynecologic Cancer Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2) Availability & Effect of Post-OP Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer Interactive Educational Website for Women With Ovarian Cancer & Caregivers PH I SRC Kinase, Dasatinib Combo Paclitaxel & Carboplatin in Pts w Ovarian, Peritoneal, & Tubal Cancer Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients With Advanced Epithelial Ovarian Cancer Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer Newton Study (NEW Dosing mainTenance Therapy Ovarian caNcer) Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Liposomal Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Liposomal Doxorubicin and Etoposide in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers Intraperitoneal Therapy For Ovarian Cancer With Carboplatin Trial Femara (Letrozole) Versus Placebo for Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer SCH-58500 in Treating Patients With Primary Ovarian, Fallopian Tube, or Peritoneal Cancer (C95084) Cisplatin and Gemcitabine in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Monoclonal Antibody Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission Letrozole in Patients With Ovarian Tumors Tivozanib As Maintenance Therapy In GYN Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer Low Dose Cyclophosphamide +/– Nintedanib in Advanced Ovarian Cancer Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal Cancer Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer – A Feasibility Study Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer HIPEC After Initial CRS in Patients Who Have Received NACT Study of Ramucirumab in Ovarian Cancer Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Erlotinib and Carboplatin in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum Vaccine Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Capecitabine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC). Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Trial of Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma Genomic BRCA and Extensive ovArian Cancer Testing A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43) Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer EGEN-001 and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer Neoadjuvant Therapy for Ovarian Cancer Neo-adjuvant Pembrolizumab in Primary Stage IV Ovarian Cancer Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin 18F-CP18 Imaging Studies for Cancer Treatment With Birinapant Phase 2, A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer Depression Treatment and Screening in Ovarian Cancer Patients Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel Bevacizumab for Primary Ovarian Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer Anti—PD-L1 and SAbR for Ovarian Cancer Autologous OC-L Vaccine and Ovarian Cancer S9912 Combination Chemo in Stage III Ovarian Cancer, Study of Paclitaxel in Patients With Ovarian Cancer Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Retrospective Case Study to Validate Existing Chemoresponse Marker Test in Ovarian, Peritoneal or Fallopian Cancer Cases TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma PDL-1 Inhibition and Focal Sensitizing Radiotherapy in Recurrent Ovarian/Primary Peritoneal/Fallopian Tube Cancers. Guadecitabine and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Belinostat and Carboplatin in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Carboplatin or Cisplatin Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Physical Activity Monitored by Fitbit Charge 2 in Improving Quality of Life in Participants With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer RO4929097 in Treating Patients With Recurrent and/or Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Vaccine Therapy and Cyclophosphamide in Treating Patients With Stage II-III Breast or Stage II-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Vinorelbine in Relapsed Platinum Resistant or Refractory C5 High Grade Serous, Endometrioid, or Undifferentiated Primary Peritoneum, Fallopian Tube or Ovarian Cancer Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Decitabine, Vaccine Therapy, and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer Study of Prolanta™ in Recurrent or Persistent Epithelial Ovarian Cancer A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second Remission Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer Phase II ABT-888 With Cyclophosphamide PD 0360324 and Cyclophosphamide in Treating Patients With Recurrent High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2) Docetaxel With or Without Phenoxodiol in Treating Patients With Recurrent Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Combination Chemotherapy and Autologous Peripheral Stem Cell Transplant in Treating Patients With Stage III, Stage IV, or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Biomarkers in Predicting Response in Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Treated on GOG-0172 or GOG-0182 Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen Pazopanib Hydrochloride, Paclitaxel, and Carboplatin in Treating Patients With Refractory or Resistant Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer Liposome-Encapsulated Doxorubicin Citrate With or Without Gemcitabine Hydrochloride in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Carboplatin With or Without Decitabine in Treating Patients With Progressive, Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Vaccine Therapy and OPT-821 or OPT-821 Alone in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer in Complete Remission Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Study of Mirvetuximab Soravtansine in Comb. With Bevacizumab, Carboplatin, PLD, Pembrolizumab, or Bevacizumab + Carboplatin in Adults With FRa + Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer AMG 706 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer Paclitaxel + Carboplatin With AVB-S6-500 in Women With Stage III or IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Receiving Neoadjuvant Chemotherapy ZD9331 With or Without Topotecan in Treating Patients With Refractory or Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Homologous Recombination Inquiry Through Ovarian Malignancy Investigations Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer Trial of Best Supportive Care and Either Cisplatin or Paclitaxel to Treat Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer and Inoperable Malignant Bowel Obstruction Pegylated Liposomal Doxorubicin Hydrochloride, Carboplatin, Veliparib, and Bevacizumab in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Carboplatin, Gemcitabine Hydrochloride, and ATR Kinase Inhibitor VX-970 in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer PH3 Study of Mirvetuximab Soravtansine vs Investigator’s Choice of Chemotherapy in Women With FRa+ Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer A Study of Mirvetuximab Soravtansine in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer Pemetrexed Disodium and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Viral Therapy in Treating Patients With Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Did Not Respond to Platinum Chemotherapy SJG-136 in Treating Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer That Did Not Respond to Previous Treatment With Cisplatin or Carboplatin A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer Predictors of Relapse of Ovarian, Peritoneal, and Fallopian Tube Cancers Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Safety Study Involving Oxaliplatin With Docetaxel for Recurrent Ovarian,Primary Peritoneal, and Fallopian Tube Cancer PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer

Brief Title

Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Official Title

A Phase 2 Study of Olaparib and Cediranib for the Treatment of Recurrent Ovarian Cancer

Brief Summary

      This phase II trial studies how well olaparib and cediranib maleate work in treating patients
      with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent).
      Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To evaluate the association of BROCA-homologous recombination (HR) with the clinical
      activity of cediranib maleate (cediranib)/olaparib, as measured by progression-free survival
      (PFS), in women with recurrent platinum-sensitive ovarian cancer.

      II. To assess the clinical activity of cediranib/olaparib, as measured by objective response,
      in women with recurrent platinum-resistant ovarian cancer.

      SECONDARY OBJECTIVES:

      I. To assess overall survival (OS), objective response, and clinical benefit (stable disease
      [SD] or response >= 16 weeks) in women with platinum-sensitive ovarian cancer, and PFS, OS,
      and clinical benefit in women with platinum-resistant ovarian cancer.

      II. To assess the safety of cediranib/olaparib in women with recurrent platinum-sensitive and
      -resistant ovarian cancer.

      III. To evaluate the association of circulating endothelial cells at baseline and day 3 with
      the clinical activity of cediranib/olaparib, as measured by PFS, in women with
      platinum-sensitive and -resistant ovarian cancer.

      IV. To evaluate changes in BROCA-HR status between archival and pre-treatment biopsy samples.

      V. To evaluate the associate of BROCA-HR with the clinical activity of cediranib/olaparib as
      measured by PFS, in women with platinum-resistant ovarian cancer.

      VI. To characterize genomic alteration by whole exome sequencing in women with
      platinum-sensitive and -resistant ovarian cancer.

      VII. To identify biomarker signatures that correlate with the clinical activity of
      cediranib/olaparib in women with recurrent platinum-sensitive and -resistant ovarian cancer,
      including changes in gene expression or acquired mutations in on-treatment tumor biopsies
      that are associated with clinical activity, and changes in gene expression or acquired
      mutations in post-progression biopsies that are associated with clinical resistance.

      VIII. To explore changes in biomarker signatures and candidate angiogenic markers from
      pre-treatment to post-progression in women with platinum-sensitive and -resistant ovarian
      cancer.

      IX. To evaluate the population pharmacokinetics (PK) of the combination of cediranib and
      olaparib (tablets) in platinum-sensitive and platinum-resistant ovarian cancer.

      EXPLORATORY OBJECTIVES:

      I. To determine the feasibility of a mobile phone application (app) ecediranib-olaparib (eCO)
      to collect patient-generated blood pressure and symptom data based upon study protocol
      recommendations.

      II. Assess patient and health care professional perceived usability and satisfaction of the
      eCO app (for patients) and of a connected web portal (for health care providers).

      III. Assess the number of generated alerts to the study team (via the web portal and email
      "high" alerts) based on pre-determined severity levels.

      OUTLINE:

      Patients receive olaparib orally (PO) twice daily (BID) and cediranib maleate PO once daily
      (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up for 30 days.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression-free survival

Secondary Outcome

 Overall survival

Condition

Fallopian Tube Endometrioid Adenocarcinoma

Intervention

Cediranib Maleate

Study Arms / Comparison Groups

 Treatment (olaparib and cediranib maleate)
Description:  Patients receive olaparib PO BID and cediranib maleate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

72

Start Date

December 4, 2015


Primary Completion Date

February 11, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have histologically or cytologically confirmed ovarian cancer,
             peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of
             either high grade serous or high grade endometrioid cancer based on local
             histopathological findings; participants with a deleterious BRCA-mutation on a
             commercial Clinical Laboratory Improvement Amendments (CLIA) assay with other
             high-grade histologies are also eligible

               -  Due to the long acceptance of BRCA testing through Myriad, Myriad testing will be
                  accepted as documentation of a deleterious mutation; if testing for BRCA is done
                  by other organizations, documentation from a qualified medical professional
                  (e.g., ovarian cancer specialty physician involved in the field, high risk
                  genetics physician, genetics counselor) listing the mutation and confirming that
                  the laboratory results show a recognized germline deleterious BRCA1 or BRCA2
                  mutation or BRCA rearrangements is required to document the presence of a
                  deleterious mutation

          -  Participants must have measurable disease via Response Evaluation Criteria in Solid
             Tumors (RECIST) 1.1, defined as at least one lesion that can be accurately measured in
             at least one dimension (longest diameter to be recorded for non-nodal lesions and
             short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm
             with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or
             calipers by clinical exam

          -  Patients may not have received prior poly ADP ribose polymerase (PARP) inhibitors

          -  Patients may have received but may not have progressed on prior anti-angiogenic
             therapy in the upfront setting

          -  For platinum sensitive cohort

               -  Cancer that has not progressed within 6 months of the last receipt of
                  platinum-based chemotherapy

               -  No limit on the number of platinum-based lines

               -  No more than one prior non-platinum based line of therapy in the recurrent
                  setting

          -  For platinum-resistant or -refractory cohort

               -  Disease that has progressed within 6 months of the last receipt of platinum-based
                  chemotherapy

               -  No more than 1 prior line of therapy in the platinum-resistant/-refractory
                  setting

               -  No limit on number of prior lines received in the platinum-sensitive setting
                  prior to development of platinum-resistance (defined as disease progression
                  within 6 months of platinum-based chemotherapy)

          -  Hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will
             not count towards line limit considerations

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Hemoglobin >= 10 g/dL

          -  Platelets >= 100,000/mcL

          -  Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 3 x institutional upper limit of normal

          -  Creatinine less than or equal to the institutional upper limit of normal or creatinine
             clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above
             institutional normal

          -  Proteinuria less than or equal to 1+ proteinuria on two consecutive dipsticks taken no
             less than week apart, or a urine protein:creatinine (UPC) ration of =< 1

          -  Coagulation parameters (international normalized ratio [INR], activated partial
             thromboplastin time [aPTT]) =< 1.25 x ULN institutional limits, except where a lupus
             anti-coagulant has been confirmed

          -  Presence of biopsiable disease and willingness to undergo pre-treatment biopsy

          -  The effects of olaparib and cediranib on the developing human fetus are unknown; for
             this reason, women of child-bearing potential and men must agree to use adequate
             contraception (hormonal or barrier method of birth control; abstinence) prior to study
             entry, for the duration of study participation, and up to 3 months after end of
             treatment; should a woman become pregnant or suspect she is pregnant while she or her
             partner is participating in this study, she should inform her treating physician
             immediately

          -  Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and
             thyroid stimulating hormone (TSH) less than or equal to the upper limit of normal

          -  Patients must be able to tolerate oral medications and not have gastrointestinal
             illnesses that would preclude absorption of cediranib or olaparib

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Willingness to release and confirmed availability of archival tissue sample for
             research purposes

          -  Willingness and ability to check and record daily blood pressure readings; blood
             pressure cuffs will be provided to patients

        Exclusion Criteria:

          -  Participants may not have had chemotherapy or radiation therapy (RT) within 3 weeks (6
             weeks for nitrosoureas or mitomycin C) prior to entering the study and must have
             recovered to =< grade 1 from adverse events due to agents administered more than 3
             weeks earlier; patients should not have received hormonal therapy for treatment of
             their cancer within 2 weeks of study entry

          -  Participants should not have received any other investigational agents nor have
             participated in an investigational trial within the past 4 weeks

          -  Participants may not have had prior use of PARP inhibitors; patients may not have
             received prior treatment affecting the VEGF pathway in the recurrent setting,
             including but not limited to thalidomide, bevacizumab, sunitinib, or sorafenib

          -  Participants may not have any evidence of ongoing inadequately controlled hypertension
             (defined as a systolic blood pressure [BP] of > 140 mmHg or a diastolic BP of > 90
             mmHg); patients with hypertension may not be on more than three antihypertensive
             medications for management of their blood pressure (medications that combine two
             anti-hypertensives into one are considered as two medications); it is strongly
             recommended that patients who require three antihypertensive medications for baseline
             management of pre-existing hypertension be actively followed by a cardiologist or
             blood pressure specialist for management of BP while on protocol

          -  Participants may not have had any prior history of hypertensive crisis or hypertensive
             encephalopathy

          -  Participants may not have had history of abdominal fistula or gastrointestinal
             perforation; patients with a history of abdominal fistula will be considered eligible
             if the fistula has healed or was surgically repaired, there has been no evidence of
             fistula for at least 6 months, and patient is deemed to be at low risk of recurrent
             fistula

          -  Participants may not have had a history of intra-abdominal abscess within the past 3
             months

          -  Participants may not have current signs and/or symptoms of bowel obstruction or signs
             and/or symptoms of bowel obstruction within 3 months prior to starting study drugs

          -  Participants may not have a dependency on intravenous (IV) hydration or total
             parenteral nutrition (TPN)

          -  Participants with any concomitant or prior invasive malignancies are ineligible with
             the following exceptions:

               -  Treated limited-stage basal cell or squamous cell carcinoma of the skin

               -  Carcinoma in situ of the breast or cervix

               -  Primary endometrial cancer meeting the following conditions: stage not greater
                  than IA, grade 1 or 2, no more than superficial myometrial invasion, without
                  vascular or lymphatic invasion; no poorly differentiated subtypes, including
                  papillary serous, clear cell, or other International Federation of Gynecology and
                  Obstetrics (FIGO) grade 3 lesions

               -  Prior cancer treated with curative intent with no evidence of recurrent disease 3
                  years following diagnosis and judged by the investigator to be at low risk of
                  recurrence

          -  Participants with any of the following:

               -  History of myocardial infarction within six months

               -  Unstable angina

               -  New York Heart Association (NYHA) classification of III or IV

          -  If cardiac function assessment is clinically indicated or performed: participants will
             be ineligible if left ventricular ejection fraction (LVEF) is less than normal per
             institutional guidelines, or < 55%, if the threshold for normal is not otherwise
             specified by institutional guidelines

          -  Patients with any of the following risk factors should have a baseline cardiac
             function assessment:

               -  Prior treatment with anthracyclines

               -  Prior treatment with trastuzumab

               -  Prior central thoracic radiation therapy (RT), including RT to the heart

               -  History of myocardial infarction within 6 to 12 months (patients with history of
                  myocardial infarction within 6 months are excluded from the study

               -  A NYHA classification of II controlled with treatment

               -  Prior history of impaired cardiac function

          -  Participants may not have had a history of a stroke or transient ischemic attack
             within six months

          -  Participants should not have clinically significant peripheral vascular disease or
             vascular disease (including aortic aneurysm or aortic dissection)

          -  Participants may not have a major surgical procedure, open biopsy, or significant
             traumatic injury within 28 days prior to starting cediranib

          -  Participants should not have any uncontrolled intercurrent illness including, but not
             limited to ongoing or active infection, symptomatic congestive heart failure, unstable
             angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
             would limit compliance with study requirements

          -  Patients with untreated brain metastases, spinal cord compression, or evidence of
             symptomatic brain metastases or leptomeningeal disease as noted on computed tomography
             (CT) or magnetic resonance imaging (MRI) scans are ineligible; screening imaging to
             rule out brain metastases is not required for screening, but should be performed prior
             to study enrollment if clinically indicated; patients with treated brain metastases
             must demonstrate stable post-therapeutic imaging and resolution of any associated
             symptoms and must be stably off steroids with no symptoms for at least 6 months
             following therapy prior to starting study drug

          -  Participants may not have a history of allergic reactions attributed to compounds of
             similar chemical or biologic composition to cediranib or olaparib

          -  Participants receiving any medications or substances that are strong inhibitors or
             inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or moderate
             inhibitors of CYP3A4 are ineligible; the study team should check a frequently-updated
             medical reference for a list of drugs to avoid or minimize use of; as part of the
             enrollment/informed consent procedures, the patient will be counseled on the risk of
             interactions with other agents, and what to do if new medications need to be
             prescribed or if the patient is considering a new over-the-counter medicine or herbal
             product; dihydropyridine calcium-channel blockers are permitted for management of
             hypertension

          -  Pregnant women are excluded from this study because olaparib and cediranib have the
             potential for teratogenic or abortifacient effects; because there is an unknown but
             potential risk for adverse events in nursing infants secondary to treatment of the
             mother with olaparib and cediranib, breastfeeding should be discontinued if the mother
             is treated with cediranib and olaparib; these potential risks may also apply to other
             agents used in this study

          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
             therapy are ineligible because of the potential for pharmacokinetic interactions with
             cediranib or olaparib; in addition, these patients are at increased risk of lethal
             infections when treated with marrow-suppressive therapy; appropriate studies will be
             undertaken in patients receiving combination antiretroviral therapy when indicated

          -  Participants should not have evidence of coagulopathy or bleeding diathesis;
             therapeutic anticoagulation for prior thromboembolic events is permitted

          -  Current use of a prohibited medication; the following medications or non-drug
             therapies are prohibited:

               -  Other anti-cancer therapy while on study treatment

               -  Prophylactic use of bisphosphonates in patients without bone disease, except for
                  the treatment of osteoporosis

               -  Because the composition, PK, and metabolism of many herbal supplements are
                  unknown, the concurrent use of all herbal supplements is prohibited during the
                  study (including, but not limited to, cannabis, St. John's wort, kava, ephedra
                  [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto,
                  or ginseng)

               -  Raloxifene is allowed for patients taking it for bone health

          -  Participants may not have any features suggestive of myelodysplastic syndrome (MDS) or
             acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if
             clinically indicated
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Joyce F Liu, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02345265

Organization ID

NCI-2015-00051

Secondary IDs

NCI-2015-00051

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Joyce F Liu, Principal Investigator, Dana-Farber - Harvard Cancer Center LAO


Verification Date

June 2020