Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Related Clinical Trial
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer A Phase 1b/2 Clinical Study to Evaluate the Safety and Tolerability and Efficacy of AZD4547 Value of Cortactin Expression in Invasive and Non-invasive Urinary Bladder Urothelial Carcinoma in Egyptian Population Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis. A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP Study) Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) En Bloc TURBT With Collins Loop vs Conventional TURBT Anlotinib Combined With Platinum/Gemcitabine for First Line Treatment of Advanced Urothelial Carcinoma A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JS004 in Advanced Solid Tumors 89Zr-girentuximab PET in Urothelial Cancer Patients Urothelial Tumor Risk Genes Detection With Genetron Uro V1 Phase I BLASST-3 Trial Bio Clinical Collection of Urothelial Carcinoma Glycosylation of Exosomes in Prostate and Urothelial Carcinoma Nivolumab for the Treatment of Patients With Metastatic Urothelial Cancer With ARID1A Mutation and Stratify Response Based on CXCL13 Expression Efficacy and Utility of Cxbladder Tests in Hematuria Patients Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab A Study of RC48-ADC in Patients With HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma Checkpoint Inhibition With or Without Domatinostat in Urothelial Cancer Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents Neoadjuvant Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Carcinoma Multimodal Spectroscopy to Detect Urothelial Cancer in Urine A Phase 3 Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer Study With Bispecific Antibody Engaging T-cells, in Patients With Progressive Cancer Diseases With Positive PSCA Marker Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial Neoadjuvant Durvalumab Alone Versus Durvalumab With Olaparib in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas A Study of ICP-192 in Patients With Advanced Solid Tumors Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Local Advanved Bladder Cancer GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma Fear of Cancer Recurrence in Genitourinary Cancer Study of Sacituzumab Govitecan (IMMU-132) in Metastatic or Locally Advanced Unresectable Urothelial Cancer Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV A Multicenter Cancer Biospecimen Collection Study Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers A Study of the Safety and Tolerance of CAN04 in Combination With Pembrolizumab in Subjects With Solid Tumors A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies A Prospective, Multi-centre, Single-blinded Study of UroCAD for Urothelial Carcinoma Diagnosis and Follow-up Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications LITT and Pembrolizumab in Recurrent Brain Metastasis Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s) Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma A Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers A Study of ZN-c3 in Participants With Solid Tumors Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors TPST-1120 as Monotherapy and in Combination With (Nivolumab, Docetaxel or Cetuximab) in Subjects With Advanced Cancers SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors Veliparib, Paclitaxel, and Carboplatin in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery and Liver or Kidney Dysfunction Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors GEN1046 Safety Trial in Patients With Malignant Solid Tumors Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors Study of the CD40 Agonistic Monoclonal Antibody APX005M A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen MV-NIS Infected Mesenchymal Stem Cells in Treating Patients With Recurrent Ovarian Cancer Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer Brivanib Alaninate in Treating Patients With Recurrent or Persistent Endometrial Cancer B-Receptor Signaling in Cardiomyopathy Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer First-Line Treatment of Bevacizumab, Carboplatin, and Paclitaxel in Treating Participants With Stage III-IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Development of Diagnostics and Treatment of Urological Cancers Breathomics as Predictive Biomarker for Checkpoint Inhibitor Response A Study of Personalized Neoantigen Cancer Vaccines A Study Combining the M3814 Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansion in High Grade Serous Ovarian Cancer and Low Grade Serous Ovarian Cancer Patients A Study Evaluating MM-310 in Patients With Solid Tumors MV-NIS or Investigator’s Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer Study of INBRX-106 in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) Study of INBRX-105 in Patients With Solid Tumors, Hodgkin or Non-Hodgkin Lymphoma Olaparib or Cediranib Maleate and Olaparib Compared With Standard Platinum-Based Chemotherapy in Treating Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy Intraperitoneal Bortezomib and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed by Surgery or Gynecological Cancers The Effects of Moderate Exercise on Distress, Quality of Life, and Biomarkers of Angiogenesis and Chronic Stress in Ovarian Cancer Survivors Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR) Water Versus Saline as Irrigation Fluid for Ureteroscopy A Study of a Personalized Neoantigen Cancer Vaccine Phase I Study of Vorinostat in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies. QUILT-3.055: A Study of ALT-803 in Combination With PD-1/PD-L1 Checkpoint Inhibitor in Patients With Advanced Cancer Prospective Trial for Examining Hematuria Using Computed Tomography Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer Trial of CRLX101, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers Dual Energy CT vs Standard Triple Phase CT-A Randomised Control Trial Expressing Personalized Tumor Antigens Study Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice A Study of Two Dosing Schedules of Atezolizumab in Combination With Gemcitabine and Cisplatin as First-Line Treatment for Metastatic Bladder Cancer Apatinib With Pembrolizumab in Previously Treated Advanced Malignancies Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors The Efficacy and Safety of UGN-102 as a Primary Chemoablative Therapy in Patients With LG NMIBC at Intermediate Risk of Recurrence A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors ( PIVOT-02 ) A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer Testing the PD-1 Inhibitor Pembrolizumab as Maintenance Therapy After Initial Chemotherapy in Metastatic Bladder Cancer Neoadjuvant Pembrolizumab in Combination With Gemcitabine Therapy in Cis-eligible/Ineligible UC Subjects Relationship of Ochratoxin A to Upper Urologic Cancers Patient-reported Outcomes in Bladder Cancer Confocal Laser Endomicroscopy in the Lower Urinary Tract Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder A Study of a CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-1 (Pembrolizumab) in Patients With Select Advanced or Metastatic Solid Tumors A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors A Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer CHEckpoint Inhibition in Combination With an Immunoboost of External Body Radiotherapy in Solid Tumors QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer A Study of RC48-ADC(Antibody Drug Conjugate) and JS001 to Evaluate the Safety and Pharmacokinetics of Subjects With Locally Advanced or Metastatic Urothelial Cancer A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer Derazantinib and Atezolizumab in Patients With Urothelial Cancer Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer Predictive Factorsfor Final Pathologic Ureteral Sections The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder Cancer A Combination of Avelumab and Taxane (AVETAX) for Urothelial Cancer Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer Investigation and Detection of Urological Neoplasia in Patients Referred With Suspected Urinary Tract Cancer: Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer 18Fluorine-Fluciclovine PET/CT for Staging Muscle Invasive Bladder Cancer Preceding Radical Cystectomy A Trial With Vinflunine in Patients With Metastatic Bladder Cancer and Impaired Renal Function A Study of BBI503 in Adult Patients With Advanced Urologic Malignancies The Cxbladder Hematuria Clinical Utility Study Cabozantinib for Advanced Urothelial Cancer A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer (POUT) Lymph Node Processing Protocol for Radical Cystectomy and Pelvic Lymph Node Dissection in Bladder Cancer Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer Famitinib Plus Anti-PD1 Therapy for Advanced Urinary System Tumor, Advanced Gynecological Tumors Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib Plus JNJ-63723283 (Cetrelimab), an Anti-PD-1 Monoclonal Antibody, in Participants With Metastatic or Locally Advanced Urothelial Cancer With Selected FGFR Gene Alterations PF-03446962 in Relapsed or Refractory Urothelial Cancer Improve Checkpoint-blockade Response in Advanced Urothelial Cancer Feasibility Evaluation of Magnetic Resonance Imaging and Positron Emission Tomography for Bladder Cancer Diagnosis and Staging Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC A Phase I/II Trial of AEZS-108 in Urothelial Cancer Patients Who Failed Platinum-chemotherapy Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Pilot Study of BC-819/PEI and BCG in Patients With Superficial Transitional Cell Bladder Carcinoma A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma Paclitaxel and Pembrolizumab in Treating Patients With Refractory Metastatic Urothelial Cancer Efficacy and Safety of UGN-101 in Recurrent Patients Prospective Multicentric Evaluation of a Bladder Preservation Strategy Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy ADAPT-BLADDER: Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder Evaluation of NanoDoce® in Participants With Urothelial Carcinoma Intravesically Heated Thermo-chemotherapy With Mitomycin-C Prior to TURBT Atezolizumab + Guadecitabine in Patients With Checkpoint Inhibitor Refractory or Resistant Urothelial Carcinoma Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma SAbR Induced Innate Immunity in Urothelial Carcinoma, Melanoma, and Cervical Carcinoma Single Agent Abraxane as Second Line Therapy in Bladder Cancer KYN-175 in Patients With Advanced or Metastatic Solid Tumors and Urothelial Carcinoma A Single Arm, Multicenter, Phase II Trial of RAD001 as Monotherapy in the Palliative Treatment of Patients With TCC After Failure of Chemotherapy TRC105 in Adults With Advanced/Metastatic Urothelial Carcinoma Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer JAVLOR® Online Non-Interventional Trial A Study to Investigate The Effectiveness Of Atezolizumab In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce) Neoadjuvant Dose Dense MVAC in MIBC and Locally Advanced Urothelial Carcinoma Alisertib in Chemotherapy-pretreated Urothelial Cancer Phase I Study With Sorafenib in Addition to Vinflunine in Metastatic Transitional Cell Carcinoma of the Urothelial Tract Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy The Effectiveness and Safety of Intravesical Docetaxel Instillation for Prevent Bladder Recurrence Study of Sitravatinib and Nivolumab in Urothelial Carcinoma Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence Biological Effect of Vitamin D in Patients With Urothelial Carcinoma Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder Study of Neoadjuvant Ipilimumab in Patients With Urothelial Carcinoma Undergoing Surgical Resection Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011) Phase I Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma Arsenic Methylation Enzymes, Cigarette Metabolites, DNA Repair Enzymes, Inflammatory Factors and Urothelial Carcinoma Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma A Study on Toripalimab Plus Nab-Paclitaxel With or Without Cisplatin as First-line Treatment of Urothelial Carcinoma Study of Tipifarnib in Patients With Previously-Treated, Advanced, HRAS Mutant Urothelial Carcinoma First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma Four Cycles Versus Six Cycles of Cisplatin-based Chemotherapy in Metastatic Urothelial Carcinoma Study of Pembrolizumab and Ramucirumab in Pts With Progressive TCC After Treatment With an Immune Checkpoint Inhibitor A Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-based Treatment Combinations in Patients With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy The Cxbladder Monitoring Study Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina A Clinical Study of PD-L1 Antibody ZKAB001(Drug Code) in Locally Advanced and Metastatic Urothelial Carcinoma Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium Application of UCAD for Diagnosing Urothelial Carcinoma. A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma CLE Characteristics of Upper Urinary Tract Urothelial Carcinoma EGCG Modulate the Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells A Trial of Cabazitaxel for Advanced Transitional Cell Carcinoma (TCC) Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC Weekly TP-HDFL in the Treatment of Advanced TCC Detecting Transitional Cell Carcinoma From Haematuria Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU) Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma Trebananib (AMG 386) in Combination With Docetaxel for Advanced Urothelial Carcinoma Vasculogenic Mimicry in Urothelial Carcinoma Treatment of Locally Advanced or Metastatic Transitional Cell Carcinoma With Cabazitaxel Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma DNA Methylation and Urothelial Carcinoma JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin DNA Methylation and Arsenic-associated Urothelial Carcinoma Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma.

Brief Title

Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Official Title

A Phase I Study of Intravenous Carboplatin/Paclitaxel or Intravenous and Intraperitoneal Paclitaxel/Cisplatin in Combination With Continuous or Intermittent /CTEP-Supplied Agent ABT-888 (NSC #737664) and CTEP-Supplied Agent Bevacizumab (NSC #704865) in Newly Diagnosed Patients With Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Brief Summary

      This phase I trial studies the side effects and best dose of veliparib when given together
      with carboplatin, paclitaxel, and bevacizumab in treating patients with newly diagnosed stage
      II-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer. Veliparib may stop
      the growth of tumor cells by blocking some of the enzymes needed for cells to repair
      themselves from damage and survive. Drugs used in chemotherapy, such as carboplatin and
      paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab, a
      type of drug called a monoclonal antibody, blocks tumor growth by targeting certain cells and
      preventing the growth of new blood vessels that tumors need to grow. Giving veliparib
      together with carboplatin, paclitaxel, and bevacizumab may kill more tumor cells.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities of ABT-888
      (veliparib) when administered using continuous versus intermittent dosing schedules with
      intravenous carboplatin, paclitaxel and bevacizumab using two different treatment regimens;
      or with intraperitoneal cisplatin and intravenous and intraperitoneal paclitaxel and
      bevacizumab in women with newly diagnosed, previously untreated, epithelial ovarian,
      fallopian tube, or primary peritoneal cancer.

      II. To determine the feasibility of these treatment regimens over four cycles in a 2-stage
      group sequential design once the MTD is established.

      III. To assess the toxicity of these regimens using Cancer Therapy Evaluation Program (CTEP)
      National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
      version 4.0.

      SECONDARY OBJECTIVES:

      I. To estimate the response rate (in measurable disease patients) and progression-free
      survival in patients treated with these treatment regimens.

      TERTIARY OBJECTIVES:

      I. To assess the extent of poly-ADP-ribose polymerase (PARP) inhibition in peripheral blood
      mononuclear cells (PBMCs) on day 1 of cycles 1 and 2.

      II. To assess genomic breast cancer, early onset (BRCA) mutation status in all patients in
      regimens I and II with continuous ABT-888 dosing and descriptively correlate with toxicity
      and efficacy.

      OUTLINE: This is a dose-escalation study of veliparib followed by a feasibility study.
      Patients are sequentially assigned to 1 of 3 treatment regimens.

      REGIMEN I: Patients receive paclitaxel intravenously (IV) over 3 hours, carboplatin IV over
      30 minutes, and bevacizumab IV over 30-90 minutes (beginning in course 2) on day 1. Patients
      also receive veliparib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21
      days for 6 courses. Patients then receive bevacizumab alone on day 1. Treatment with
      bevacizumab repeats every 21 days for 16 courses in the absence of disease progression or
      unacceptable toxicity.

      REGIMEN II: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Patients also
      receive carboplatin, bevacizumab, and veliparib as in Regimen I. Treatment repeats every 21
      days for 6 courses. Patients then receive bevacizumab alone on day 1. Treatment with
      bevacizumab repeats every 21 days for 16 courses in the absence of disease progression or
      unacceptable toxicity.

      REGIMEN III: Patients receive paclitaxel IV over 3 hours on day 1 and intraperitoneally (IP)
      on day 8, and cisplatin IP on day 1 or 2. Patients also receive bevacizumab and veliparib as
      in Regimen I. Treatment repeats every 21 days for 6 courses. Patients then receive
      bevacizumab alone on day 1. Treatment repeats every 21 days for 16 courses in the absence of
      disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up periodically.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of dose-limiting toxicities (DLTs) occurring in the first or second course of treatment (dose-escalation phase)

Secondary Outcome

 Objective tumor response (complete and partial response) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)

Condition

Fallopian Tube Carcinoma

Intervention

Bevacizumab

Study Arms / Comparison Groups

 Regimen I (paclitaxel, carboplatin, bevacizumab, veliparib)
Description:  Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes (beginning in course 2) on day 1. Patients also receive veliparib PO BID on days 1-21. Treatment repeats every 21 days for 6 courses. Patients then receive bevacizumab alone on day 1. Treatment with bevacizumab repeats every 21 days for 16 courses 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

Biological

Estimated Enrollment

431

Start Date

October 28, 2009

Completion Date

April 10, 2020

Primary Completion Date

September 2, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary
             peritoneal carcinoma, or carcinosarcoma stage II, III, or IV with either optimal (=< 1
             cm residual disease) or suboptimal residual disease

          -  All patients must have a procedure for determining diagnosis of epithelial ovarian,
             fallopian tube, primary peritoneal, or carcinosarcoma with appropriate tissue for
             histologic evaluation

          -  Patients with the following histologic cell types are eligible:

               -  Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma,
                  undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial
                  adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor,
                  adenocarcinoma not otherwise specified (N.O.S.) or carcinosarcoma

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to
             CTEP Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, grade 1; this
             ANC cannot have been induced or supported by granulocyte colony stimulating factors

          -  Platelets greater than or equal to 100,000/mm^3

          -  Regimens I and II: Creatinine =< 1.5 x institutional upper limit normal (ULN), CTCAE
             grade 1

               -  Regimen III: Creatinine no greater than the institutional upper limits of normal

          -  Bilirubin less than or equal to 1.5 x ULN (CTEP CTCAE version 4.0, grade 1)

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less
             than or equal to 3 x ULN (CTEP CTCAE version 4.0, grade 1)

          -  Alkaline phosphatase less than or equal to 2.5 x ULN (CTEP CTCAE version 4.0, grade 1)

          -  Albumin greater than or equal to 3.0 g/dL

          -  Neuropathy (sensory and motor) less than or equal to CTEP CTCAE version 4.0, grade 1

          -  Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN
             (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of
             therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.5 x ULN

          -  Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

          -  Patients must be entered between 1 and 12 weeks after initial surgery performed for
             the combined purpose of diagnosis, staging and cytoreduction

          -  Patients who have met the pre-entry requirements specified

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

        Exclusion Criteria:

          -  Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly
             "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary
             peritoneal or fallopian tube cancer treated with surgery only (such as patients with
             stage IA or IB low-grade epithelial ovarian or fallopian tube cancers) are not
             eligible

               -  NOTE: Patients with a prior diagnosis of a borderline tumor that was surgically
                  resected and who subsequently develop an unrelated, new invasive epithelial
                  ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that
                  they have not received prior chemotherapy for any ovarian tumor

          -  Patients with synchronous primary endometrial cancer or a past history of endometrial
             cancer, unless all of the following conditions are met:

               -  Stage not greater than IB

               -  No more than superficial myometrial invasion

               -  No 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

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer and other specific malignancies as noted, are excluded if
             there is any evidence of other malignancy being present within the last five years;
             patients are also excluded if their previous cancer treatment contraindicates this
             protocol therapy

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis are excluded; prior radiation for localized cancer of the breast, head and
             neck, or skin is permitted, provided that it was completed more than three years prior
             to registration, and the patient remains free of recurrent or metastatic disease

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor within
             the last five years are excluded; patients may have received prior adjuvant
             chemotherapy for localized breast cancer, provided that it was completed more than
             three years prior to registration, and that the patient remains free of recurrent or
             metastatic disease

          -  Patients with acute hepatitis or active infection that requires parenteral antibiotics

          -  Patients with serious non-healing wound, ulcer, or bone fracture; this includes
             history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
             within 28 days; patients with granulating incisions healing by secondary intention
             with no evidence of fascial dehiscence or infection are eligible but require weekly
             wound examinations

          -  Patients with active bleeding or pathologic conditions that carry high risk of
             bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major
             vessels

          -  Patients with history or evidence upon physical examination of central nervous system
             (CNS) disease, including primary brain tumor, seizures or history of seizures, and/or
             any CNS metastases are ineligible

          -  Patients with history of cerebrovascular accident (CVA, stroke), transient ischemic
             attack (TIA) or subarachnoid hemorrhage within six months of the first date of
             treatment on this study are ineligible

          -  Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg

          -  Myocardial infarction or unstable angina < 6 months prior to registration

          -  New York Heart Association (NYHA) class II or higher congestive heart failure

          -  Serious cardiac arrhythmia requiring medication

          -  CTEP CTCAE version 4.0, grade 2 or higher peripheral ischemia (brief [< 24 hours
             (hrs)] episode of ischemia managed non-surgically and without permanent deficit)

          -  Patients with known hypersensitivity to Chinese hamster ovary cell products or other
             recombinant human or humanized antibodies

          -  Patients with clinically significant proteinuria (urine protein creatinine ratio
             greater or equal to 1.0)

          -  Patients with invasive procedures or anticipation of invasive procedures within the
             following timeframes as defined below:

               -  Major surgical procedure, open biopsy or significant traumatic injury within 28
                  days prior to the first date of bevacizumab therapy (cycle 2)

               -  Major surgical procedure anticipated during the course of the study

               -  Core biopsy within 7 days prior to the first date of bevacizumab therapy (cycle
                  2)

          -  Patients who are pregnant or nursing

          -  Patients with clinical symptoms or signs of gastrointestinal obstruction and who
             require parenteral hydration or nutrition

          -  Patients with GOG performance status of 3 or 4
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Katherine M Bell-McGuinn, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00989651

Organization ID

NCI-2011-03730

Secondary IDs

NCI-2011-03730

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Collaborators

 NRG Oncology

Study Sponsor

Katherine M Bell-McGuinn, Principal Investigator, NRG Oncology


Verification Date

October 2021