Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT02446600)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (29 items) and avoid the listed exclusions (41 items).
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (356 Sites)
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- University of South Alabama Mitchell Cancer Institute — Mobile, Alabama
- Alaska Women's Cancer Care — Anchorage, Alaska
- Providence Alaska Medical Center — Anchorage, Alaska
- Arizona Oncology Associates-West Orange Grove — Tucson, Arizona
- Arizona Oncology Associates-Wilmot — Tucson, Arizona
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- PCR Oncology — Arroyo Grande, California
- Mercy San Juan Medical Center — Carmichael, California
- Marin Cancer Care Inc — Greenbrae, California
- UC San Diego Moores Cancer Center — La Jolla, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Palo Alto Medical Foundation-Camino Division — Mountain View, California
- Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California
- Kaiser Permanente-Oakland — Oakland, California
- Palo Alto Medical Foundation Health Care — Palo Alto, California
- Sutter Roseville Medical Center — Roseville, California
- Mercy Cancer Center - Sacramento — Sacramento, California
- Sutter Medical Center Sacramento — Sacramento, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- Kaiser Permanente Sacramento Medical Center — Sacramento, California
- California Pacific Medical Center-Pacific Campus — San Francisco, California
- Kaiser Permanente-San Francisco — San Francisco, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.