Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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Brief Title

Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Official Title

A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

Brief Summary

      This randomized phase II/III trial studies how well cediranib maleate and olaparib work when
      given together or separately, and compares them to standard chemotherapy in treating patients
      with ovarian, fallopian tube, or primary peritoneal cancer that has returned (recurrent)
      after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or
      continued to grow while being treated with platinum-based chemotherapy drugs
      (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by
      blocking enzymes needed for cell growth. Drugs used in chemotherapy 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 giving cediranib maleate and
      olaparib together may cause more damage to cancer cells when compared to either drug alone or
      standard chemotherapy.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To assess the efficacy and identify (in)active arm(s) of the combination of cediranib
      maleate (cediranib) and olaparib, cediranib alone, olaparib alone, and physician's choice
      standard of care chemotherapy, as measured by progression-free survival (PFS) in the setting
      of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube
      cancer. (Phase II) II. To assess the efficacy of the combination of cediranib and olaparib,
      and cediranib monotherapy, as measured by overall survival (OS) and PFS, as compared to
      physician's choice standard of care chemotherapy in women with recurrent platinum-resistant
      or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)

      SECONDARY OBJECTIVES:

      I. To assess the efficacy of the combination of cediranib and olaparib, cediranib alone,
      olaparib alone, and physician's choice standard of care chemotherapy, as measured by
      objective response rate (ORR: partial or complete response) by Response Evaluation Criteria
      in Solid Tumors (RECIST) 1.1 criteria, in the setting of recurrent platinum-resistant
      or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase II) II. To assess
      safety endpoints, as measured by frequency and severity of adverse events by Common
      Terminology Criteria for Adverse Events (CTCAE). (Phase II and Phase III) III. To assess the
      efficacy of the combination of cediranib and olaparib, and cediranib monotherapy, as measured
      by ORR as compared to physician's choice standard of care chemotherapy in the setting of
      recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube
      cancer. (Phase III)

      OBJECTIVES WITH INTEGRATED BIOMARKERS:

      I. To assess correlation of homologous recombination deficiency (HRD) status, as assessed via
      BROCA-HR assay with response, as measured by PFS and ORR. (Phase II) II. To evaluate the
      prognostic and predictive role of circulating endothelial cells (CEC) on comparative
      effectiveness of targeted therapies and reference chemotherapy. (Phase II) III. To evaluate
      quality of life data compliance, as measured by the 9-item Disease Related Symptoms (DRS-9)
      subscale of the National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer
      Therapy (FACT) Ovarian Symptom Index (NFOSI) for utilization and analysis in the Phase III
      study. (Phase II) IV. To assess correlation of HRD status, as assessed via BROCA-HR assay
      with response, as measured by OS, PFS and ORR. (Phase III) V. To evaluate the prognostic and
      predictive role of circulating endothelial cells (CEC) on comparative effectiveness of
      targeted therapies and reference chemotherapy. (Phase III) VI. To assess the effect on
      disease-related symptoms (DRS) as measured by the 9-item DRS-P subscale of the NCCN-FACT
      Ovarian Symptom Index-18 (NFOSI-18), of single agent cediranib and cediranib/olaparib
      combination, compared to standard chemotherapy, in the setting of recurrent
      platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase
      III)

      EXPLORATORY OBJECTIVES:

      I. To assess exploratory biomarkers of potential HRD, including genomic scarring, BRCA1
      methylation, BRCA1 protein expression, and mutations in NHEJ, and other genes that might
      modify HRD. (Phase II and Phase III) II. To evaluate the prognostic and predictive role of
      angiogenic biomarkers, as assessed by the Duke plasma angiome. (Phase II and Phase III) III.
      To 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/GOG-Ntx-4, and health utility as measured by the EQ-5D, of
      single agent cediranib and cediranib/olaparib combination, compared to standard chemotherapy,
      in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or
      fallopian tube cancer. (Phase III)

      OUTLINE:

      PHASE II: Patients are randomized to 1 of 4 treatment arms.

      ARM I (REFERENCE REGIMEN): Patients undergo physician's choice of standard of care
      chemotherapy, comprising either paclitaxel intravenously (IV) on days 1, 8, 15, and 22 every
      28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV on day 1 every 28 days
      (Regimen II); or topotecan hydrochloride IV on days 1, 8, and 15 every 28 days or days 1-5
      every 21 days (Regimen III). Treatment continues in the absence of disease progression or
      unacceptable toxicity. No modification of the assigned regimens, such as additional drugs
      (gemcitabine, or bevacizumab) is allowed. (12/05/2016)

      ARM II (CEDIRANIB MALEATE AND OLAPARIB): Patients receive cediranib maleate orally (PO) once
      daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of
      disease progression or unacceptable toxicity.

      ARM III (CEDIRANIB): Patients receive cediranib maleate PO daily continuously. Cycles repeat
      every 28 days in the absence of disease progression or unacceptable toxicity.

      ARM IV (OLAPARIB): Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days
      in the absence of disease progression or unacceptable toxicity. (In July 2018, the Data
      Monitoring Committee voted to exclude the olaparib alone regimen).

      PHASE III: Patients are randomized to 1 of 3 treatment arms.

      ARM I (REFERENCE REGIMEN): Patients undergo physician's choice standard of care chemotherapy
      as in Phase II Arm I. No modification of the assigned regimens, such as additional drugs
      (gemcitabine or bevacizumab) is allowed. (12/05/2016)

      ARM II (CEDIRANIB AND OLAPARIB): Patients receive cediranib maleate PO and olaparib PO as in
      Phase II Arm II.

      ARM III (SINGLE AGENT): Patients receive cediranib maleate PO as determined by the Phase II
      study. 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 up to 3 years.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Progression-free survival (PFS) (Phase II and Phase III)

Secondary Outcome

 Objective response rate (partial or complete response) (Phase II and Phase III)

Condition

Fallopian Tube Clear Cell Adenocarcinoma

Intervention

Cediranib

Study Arms / Comparison Groups

 Phase II Arm I (reference regimen)
Description:  Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. (12/05/2016)

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

680

Start Date

February 5, 2016


Primary Completion Date

June 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed ovarian cancer,
             peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of
             either serous or endometrioid cancer based on local histopathological findings; both
             endometrioid and serous histology should be high-grade for eligibility of non-mutation
             carriers; patients with clear cell, mixed epithelial, undifferentiated carcinoma, or
             transitional cell carcinoma 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 BRCA testing through Myriad, Myriad testing
                  will be accepted; 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 showed
                  a recognized germ line deleterious BRCA 1 or BRCA 2 mutation or BRCA
                  rearrangement is required; a copy of Myriad or other BRCA mutational analysis
                  (positive or variants of unknown significance [VUS] or negative) reports will be
                  requested but not required for study enrollment

          -  Patients should have recurrent platinum-resistant or- refractory disease - defined as
             disease that has progressed by imaging while receiving platinum or had recurrence
             within 6 months of the last receipt of platinum-based chemotherapy; rising CA125 only
             is not considered as platinum-resistant or refractory disease

          -  Phase II study: measurable disease by RECIST 1.1 criteria; if archival tumor sample is
             not available tumor sample from fresh biopsy is acceptable

          -  Phase III study: evaluable disease - defined as RECIST 1.1 measurable disease OR
             non-measurable 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 in
             the setting of a cancer antigen [CA]125 >= 2 x upper limit of normal [ULN])

          -  No more than 3 prior treatment regimens (including primary therapy; no more than 1
             prior non-platinum based therapy in the platinum-resistant/-refractory setting);
             hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will
             not count towards this line limit

          -  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 PARP-inhibitor

          -  Patient must have provided study specific informed consent prior to study entry

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Hemoglobin >= 10 g/dL

          -  Total bilirubin within =< 1.5 times the upper limit of normal (ULN) institutional
             limits

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 3 x institutional ULN; if intrahepatic liver metastases are present, AST and ALT
             must be =< 5 times institutional ULN

          -  Creatinine =< 1.5 x the institutional ULN

          -  Urine protein: creatinine ratio urine protein creatinine (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 protein of =< 500 mg over 24 hours

          -  Toxicities of prior therapy (excepting alopecia) should be resolved to less than or
             equal to grade 1 as per CTCAE; patients with long-standing stable grade 2 neuropathy
             may be considered after discussion with the study chair.

          -  Adequately controlled blood pressure (systolic blood pressure [SBP] =< 140; diastolic
             blood pressure [DBP] =< 90 mmHg) on maximum of three antihypertensive medications;
             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; it is strongly recommended that
             patients who are on three antihypertensive medications be followed by a cardiologist
             or a primary care physician for management of BP 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 cediranib alone and the combination
             of olaparib and cediranib arms

          -  Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and
             thyroid-stimulating hormone (TSH) within normal limits

          -  Able to swallow and retain oral medications and without gastrointestinal (GI)
             illnesses that would preclude absorption of cediranib or olaparib

          -  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

          -  Olaparib adversely affects embryofetal survival and development in the rat; 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 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 3
             months after the last dose of olaparib; should a woman become pregnant or suspect she
             is pregnant while participating in this study, she should inform her treating
             physician immediately

        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

          -  Any other investigational agents within the past 4 weeks

          -  Prior treatment affecting the VEGF/VEGFR pathway or the angiopoietin pathway in the
             recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib,
             sorafenib, pazopanib, cediranib, nintedanib, and trebananib; bevacizumab used in the
             upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly
             diagnosed disease will be allowed

          -  Prior use of PARP-inhibitors

          -  CA-125 only disease without Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
             measurable or otherwise evaluable disease

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

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

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

          -  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

          -  Dependency on 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 Federation of Gynecology and
                  Obstetrics (FIGO) grade 3 lesions

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

          -  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 should not be included on this study,
             since neurologic dysfunction may confound the evaluation of neurologic and other
             adverse events; 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

          -  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 functional 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

          -  Clinical significant peripheral vascular disease or vascular disease (aortic aneurysm
             or aortic dissection)

          -  Evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior
             thromboembolic events is permitted

          -  Evidence 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)

          -  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

          -  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

          -  Known human immunodeficiency virus (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

          -  Participants receiving any medications or substances that are strong inhibitors or
             inducers of CYP3A4 are ineligible

               -  Strong inhibitors and inducers of UGT/PgP should be used with caution

          -  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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jung-min Lee, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02502266

Organization ID

NCI-2015-00651

Secondary IDs

NCI-2015-00651

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Collaborators

 Canadian Cancer Trials Group

Study Sponsor

Jung-min Lee, Principal Investigator, NRG Oncology


Verification Date

April 2021