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

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Brief Title

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

Official Title

A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Brief Summary

      This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they
      work compared with standard platinum-based chemotherapy in treating patients with
      platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back.
      Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian
      tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for
      tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine
      hydrochloride, and pegylated liposomal doxorubicin hydrochloride 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. It is not yet known whether olaparib or cediranib maleate
      and olaparib is more effective than standard platinum-based chemotherapy in treating patients
      with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
    

Detailed Description

      PRIMARY OBJECTIVE:

      I. Assess the efficacy of either single agent olaparib or the combination of cediranib
      (cediranib maleate) and olaparib, as measured by progression free survival (PFS), as compared
      to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive
      ovarian, primary peritoneal or fallopian tube cancer.

      SECONDARY OBJECTIVES:

      I. Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib,
      as measured by response rate and overall survival as compared to standard platinum-based
      chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or
      fallopian tube cancer.

      II. Assess the efficacy of single agent olaparib or the combination of cediranib and
      olaparib, as measured by PFS, in women with or without deleterious germline breast cancer
      (BRCA) mutations (gBRCAmt) in the setting of recurrent platinum-sensitive ovarian, primary
      peritoneal, or fallopian tube cancer.

      III. Assess the effect on disease-related symptoms (DRS) as measured by the 9-item DRS-P
      subscale of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy
      (NCCN-FACT) Ovarian Symptom Index-18 (NFOSI-18), of single agent olaparib or cediranib and
      olaparib, compared to standard platinum-based chemotherapy, in the setting of recurrent
      platinum sensitive ovarian, primary peritoneal or fallopian tube cancer.

      IV. Assess the efficacy of single agent olaparib or the combination of cediranib and
      olaparib, as measured by PFS, in women with or without homologous repair deficiencies as
      measured by BROCA in the setting of recurrent platinum-sensitive ovarian, primary peritoneal,
      or fallopian tube cancer.

      V. To assess changes in the number of circulating endothelial cells (CECs) following three
      days of treatment with olaparib, combination olaparib/cediranib, or standard platinum-based
      chemotherapy in women with recurrent platinum-sensitive ovarian, primary peritoneal, or
      fallopian tube cancer.

      VI. To assess whether change in the number of circulating endothelial cells (CECs) following
      three days of treatment with olaparib, combination olaparib/cediranib, or standard
      platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, primary
      peritoneal, or fallopian tube cancer is prognostic for PFS.

      VII. To develop a profile from a panel of angiogenic biomarkers in women with recurrent
      platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer which is associated
      with PFS, and then validate the predictive value of this biomarker profile.

      EXPLORATORY OBJECTIVES:

      I. To assess the time from randomization to the first non-study, anti-cancer therapy, surgery
      or death (TFST) for single-agent olaparib or combination cediranib and olaparib relative to
      standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian,
      primary peritoneal or fallopian tube cancer.

      II. To assess the time from randomization to the second non-study, anti-cancer therapy,
      surgery or death (TSST) for single-agent olaparib or combination cediranib and olaparib
      relative to standard platinum-based chemotherapy in the setting of recurrent
      platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

      III. Assess the effect on secondary measures of quality of life, as assessed by the treatment
      side effects (TSE) and function/well-being (F/WB) subscales of the NFOSI-18, sensory
      neuropathy as measured by the FACT/Gynecologic Oncology Group-Neurotoxicity version 4
      (GOG-Ntx-4), and health utility as measured by the Euro Quality of Life-5 Dimension (EQ-5D),
      of single agent olaparib or cediranib and olaparib, compared to standard platinum-based
      chemotherapy, in the setting of recurrent platinum sensitive ovarian, primary peritoneal or
      fallopian tube cancer.

      OUTLINE: Patients are randomized to 1 of 3 treatment arms.

      ARM I: Patients may be treated with one of the three regimens per investigator discretion.

      REGIMEN I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV
      over 30-60 minutes and on day 1. Treatment repeats every 21 days for at least 4 cycles in the
      absence of disease progression or unacceptable toxicity.

      REGIMEN II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and
      carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 for at least 4 cycles
      in the absence of disease progression or unacceptable toxicity.

      REGIMEN III: Patients receive pegylated liposomal doxorubicin hydrochloride IV and
      carboplatin IV over 30-60 minutes and on day 1. Treatment repeats every 28 days for at least
      4 cycles in the absence of disease progression or unacceptable toxicity.

      ARM II: Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days
      in the absence of disease progression or unacceptable toxicity.

      ARM III: Patients receive olaparib PO BID and cediranib maleate PO once daily (QD). Cycles
      repeat every 28 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 2 years and
      then every 6 months for 3 years.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria

Secondary Outcome

 Overall Survival

Condition

Fallopian Tube Clear Cell Adenocarcinoma

Intervention

Carboplatin

Study Arms / Comparison Groups

 Arm I (platinum-based chemotherapy)
Description:  REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
REGIMEN II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
REGIMEN III: Patients receive pegylated liposomal doxorubicin hydrochloride IV and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 28 days for at least 4 cycles 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

579

Start Date

March 28, 2016


Primary Completion Date

February 23, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have platinum-sensitive recurrent high-grade serous or high-grade
             endometrioid ovarian, primary peritoneal, or fallopian tube cancers; patients with
             other (clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell
             carcinoma) high-risk histologies are also eligible, provided that the patient has a
             known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a
             clinical laboratory; Note: Due to the long acceptance of germline BRCA testing through
             Myriad, Myriad testing will be accepted; if testing for germline 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
             showed a recognized germline deleterious BRCA1 or BRCA2 mutation or BRCA rearrangement
             is required; please collect a copy of Myriad or other BRCA mutational analysis
             (positive or VUS or negative) reports

               -  Platinum-sensitive disease defined as no clinical or radiographic evidence of
                  disease recurrence for > 6 months (or 182 days) after last receipt of
                  platinum-based therapy

               -  Patients must have had a complete clinical response to their prior line of
                  platinum therapy and cannot have had progression through prior platinum-based
                  therapy

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

          -  Patients must have evaluable disease - defined as one of the following:

               -  Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease OR

               -  Evaluable disease (defined as solid and/or cystic abnormalities on radiographic
                  imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites
                  and/or pleural effusion that has been pathologically demonstrated to be
                  disease-related) AND a cancer antigen 125 (CA125) that has doubled from the
                  post-treatment nadir and is also greater than 2 times upper limit of normal (ULN)

          -  Prior therapy:

               -  Prior chemotherapy must have included a first-line platinum-based regimen with or
                  without intravenous consolidation chemotherapy

               -  Patients may have received an unlimited number of platinum-based therapies in the
                  recurrent setting

               -  Patients may have received up to 1 non-platinum-based line of therapy in the
                  recurrent setting; prior hormonal therapy will not be considered to count as this
                  non-platinum-based line

               -  Patients may not have had a prior anti-angiogenic agent in the recurrent setting;
                  prior use of bevacizumab in the upfront or upfront maintenance setting is allowed

               -  Patients may not have previously received a poly adenosine diphosphate (ADP)
                  ribose polymerase (PARP)-inhibitor

               -  Prior hormonal-based therapy for ovarian, primary peritoneal, or fallopian tube
                  cancer is acceptable

          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0, 1 or 2 (Karnofsky >= 60%)

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Hemoglobin >= 10 g/dL

          -  Creatinine =< the institutional upper limit of normal (ULN) OR creatinine clearance >=
             60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Urine protein: creatinine ratio (UPC) of =< 1 or less than or equal to 2+ proteinuria
             on two consecutive dipsticks taken no less than 1 week apart; UPC is the preferred
             test; patients with >= 2+ proteinuria on dipstick must also have a 24 hour urine
             collection demonstrating =< 500 mg over 24 hours

          -  Total bilirubin =< 1.5 x the institutional ULN

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3
             times institutional ULN

          -  Toxicities of prior therapy (excepting alopecia) should be resolved to less than or
             equal to grade 1 as per National Cancer Institute-Common Terminology Criteria for
             Adverse Events (NCI-CTCAE); patients with long-standing stable grade 2 neuropathy may
             be considered after discussion with the overall principal investigator (PI), but may
             not receive carboplatin and paclitaxel as the reference regimen, if randomized to that
             arm

          -  Patients must be able to swallow and retain oral medications and without
             gastrointestinal illnesses that would preclude absorption of cediranib or olaparib

          -  Patients must have adequately controlled blood pressure (BP), with a BP no greater
             than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; patients must have a
             BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2
             weeks prior to starting study; patients with hypertension may be managed with up to a
             maximum of three antihypertensive medications; it is strongly recommended that
             patients who are on three antihypertensive medications be followed by a cardiologist
             or blood pressure specialist for management of blood pressure while on protocol

          -  Patients must be willing and able to check and record daily blood pressure readings;
             blood pressure cuffs will be provided to patients randomized to Arm III

          -  Cediranib has been shown to terminate fetal development in the rat, as expected for a
             process dependent on VEGF signaling; for this reason, women of child-bearing potential
             must have a negative pregnancy test prior to study entry; women of child-bearing
             potential must agree to use two reliable forms of contraception (hormonal or barrier
             method of birth control; abstinence) prior to study entry, for the duration of study
             participation, and for 6 weeks after cediranib discontinuation; should a woman become
             pregnant or suspect she is pregnant while 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) within normal limits

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) of starting treatment or those who have not recovered
             from adverse events due to agents administered more than 4 weeks earlier; patients may
             not have had hormonal therapy within 2 weeks prior to entering the study; patients
             receiving raloxifene for bone health as per Food and Drug Administration (FDA)
             indication may remain on raloxifene absent other drug interactions

          -  Patients may not be receiving any other investigational agents nor have participated
             in an investigational trial within the past 4 weeks

          -  Patients may not be receiving any medication that may markedly affect renal function
             (e.g., vancomycin, amphotericin, pentamidine)

          -  Patients may not have received prior treatment affecting the vascular endothelial
             growth factor (VEGF) pathway (including, but not limited to thalidomide, sunitinib,
             pazopanib, sorafenib, and nintedanib); bevacizumab used in the upfront setting in
             conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease
             will be allowed

          -  Patients may not have previously received a PARP inhibitor

          -  CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease

          -  Patients with untreated brain metastases, spinal cord compression, or evidence of
             symptomatic brain metastases or leptomeningeal disease as noted on CT or MRI scans
             should not be included on this study, since neurologic dysfunction may confound the
             evaluation of neurologic and other adverse events; 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 and
             resolution of any associated symptoms must demonstrate stable post-therapeutic imaging
             for at least 6 months following therapy prior to starting study drug

          -  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) are
             ineligible; strong inhibitors and inducers of UGT/PgP should be used with caution

          -  History of gastrointestinal perforation; patients with a history of abdominal fistula
             will be considered eligible if the fistula was surgically repaired or has healed,
             there has been no evidence of fistula for at least 6 months, and patient is deemed to
             be at low risk of recurrent fistula

          -  History of intra-abdominal abscess within the past 3 months

          -  Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel
             obstruction within 3 months prior to starting study drugs

          -  Dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)

          -  Any concomitant or prior invasive malignancies with the following curatively treated
             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/serous, clear cell, or other International Federation of
                  Gynecology and Obstetrics (FIGO) grade 3 lesions

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

          -  Patients with any of the following:

               -  History of myocardial infarction within six months

               -  Unstable angina

               -  Resting electrocardiogram (ECG) with clinically significant abnormal findings

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

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

               -  Patients with 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)

                    -  Prior history of impaired cardiac function

          -  History of stroke or transient ischemic attack within six months

          -  Any prior history of hypertensive crisis or hypertensive encephalopathy

          -  Clinically significant peripheral vascular disease or vascular disease (including
             aortic aneurysm or aortic dissection)

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to starting cediranib

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia (other than atrial fibrillation with controlled ventricular rate), or
             psychiatric illness/social situations that would limit compliance with study
             requirements

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

          -  Known HIV-positive individuals are ineligible because of the potential for
             pharmacokinetic interactions with cediranib or olaparib; in addition, these
             individuals are at increased risk of lethal infections when treated with
             marrow-suppressive therapy

          -  Patients may not use any complementary or alternative medicines including natural
             herbal products or folk remedies as they may interfere with the effectiveness of the
             study treatments

          -  No features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia
             (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated

          -  No prior allogeneic bone marrow transplant or double umbilical cord blood
             transplantation (dUBCT)
      

Gender

Female

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Joyce F Liu, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02446600

Organization ID

NCI-2015-00606

Secondary IDs

NCI-2015-00606

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Collaborators

 AstraZeneca

Study Sponsor

Joyce F Liu, Principal Investigator, NRG Oncology


Verification Date

April 2021