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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)
Overall Recruitment Status: Enrollment on-hold
 
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)
 
Region Sponsors
Colorado
National Cancer Institute (NCI)
 
Acronym KP IRB No.
CO-16-2359
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Females with Fallopian Tube Cancer or Ovarian Cancer
 
Purpose
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 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
 
Gender Age Limit
Female
 
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. Participants with a deleterious germline BRCA-mutation on a commercial Clinical Laboratory Improvement Amendments (CLIA) assay with other high-grade histologies, including mucinous adenocarcinoma, clear cell, transitional cell, undifferentiated adenoca, undifferentiated carcinoma, mixed epithelial andenoca are also eligible
  • Patients should have recurrent platinum-resistant or- refractory disease - defined as disease that has progressed while receiving platinum or had recurrence within 6 months of the last receipt of platinum-based chemotherapy
  • Phase II study: measurable disease by RECIST 1.1 criteria. Baseline biopsy for retinitis pigmentosa 2 (RP2) study is optional but highly encouraged
  • 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 2 prior treatment regimens (including primary therapy). 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
 
Exclusion Criteria
  • Chemotherapy or radiation therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C). Patients must have recovered from adverse events due to agents administered more than 3 weeks earlier. Patients may not have had hormonal therapy within 2 weeks prior to entering the study
  • Any other investigational agents within the past 4 weeks
  • Prior use of poly adenosine diphosphate (ADP) ribose polymerase (PARP)-inhibitors. Prior treatment affecting the vascular endothelial growth factor (VEGF) pathway in the recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, pazopanib, cediranib, and nintedanib. Bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed
  • CA-125 only 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 except temporary (< 24 hr) improved with medical management within last 3 months
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
  • Dependency on IV hydration or total parenteral nutrition (TPN)
  • Current pregnancy. Patients must be on two forms of birth control if of child-bearing potential

 
Keywords and/or Specific Medical Conditions
  • Adenocarcinoma, Clear Cell
  • Genital Neoplasms, Female
  • Adenocarcinoma, Mucinous
  • Gonadal Disorders
  • Adnexal Diseases
  • Liposomal doxorubicin
  • Carcinoma
  • Maleic acid
  • Carcinoma, Endometrioid
  • Neoplasms
  • Carcinoma, Transitional Cell
  • Neoplasms by Histologic Type
  • Cediranib
  • Neoplasms by Site
  • Cystadenocarcinoma
  • Neoplasms, Cystic, Mucinous, and Serous
  • Cystadenocarcinoma, Serous
  • Neoplasms, Glandular and Epithelial
  • Doxorubicin
  • Ovarian Diseases
  • Endocrine Gland Neoplasms
  • Ovarian Neoplasms
  • Endocrine System Diseases
  • Urogenital Neoplasms
  • Endometrial Neoplasms
  • Uterine Neoplasms
  • Fallopian Tube Diseases
  • Adenocarcinoma
  • Fallopian Tube Neoplasms
  • Oncology (Adult)
  • Genital Diseases, Female
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Alex Menter, MD
Contact Information:
- Mabel Peters, BS
-303-764-8523
-Mabel.D.Peters@kp.org
-Franklin Medical Offices - Denver


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