Study on Combining Cediranib and Olaparib with Chemotherapy for Recurrent Platinum-Resistant Ovarian Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02502266
This clinical trial is testing whether a combination of the drugs Cediranib and Olaparib, given together or separately, is more effective than standard chemotherapy in treating ovarian, fallopian tube, or primary peritoneal cancer that has returned after platinum-based chemotherapy.
Patient Parameters
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Program Overview
The purpose of this study is to find out if using Cediranib and Olaparib together or separately can better control ovarian, fallopian tube, or primary peritoneal cancer that has come back after treatment with platinum-based chemotherapy. These drugs may work by blocking certain enzymes needed for cancer cell growth. The study will compare these treatments to standard chemotherapy to see which is more effective in stopping cancer growth.
Description
This study is divided into two phases: Phase II and Phase III.
In Phase II, researchers will evaluate how well Cediranib and Olaparib work together or separately compared to standard chemotherapy in patients with recurrent platinum-resistant or refractory ovarian, fallopian tube, or primary peritoneal cancer. The main goal is to see if these treatments can help patients live longer without the cancer getting worse.
In Phase III, the study will further assess the effectiveness of Cediranib and Olaparib, focusing on overall survival and progression-free survival compared to standard chemotherapy.
The study will also look at the safety of these treatments, the response rate of the cancer to the treatments, and the quality of life of the patients. Researchers will explore how certain genetic markers and blood tests might predict how well patients respond to the treatments.
Participants will be randomly assigned to receive either the combination of Cediranib and Olaparib, Cediranib alone, Olaparib alone, or standard chemotherapy. They will undergo regular scans and tests to monitor their health and the cancer's response to the treatment. After completing the study treatment, patients will have follow-up visits every few months for up to three years.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of ovarian, fallopian tube, or primary peritoneal cancer with specific types of cancer cells.
- The cancer must have returned or continued to grow after platinum-based chemotherapy.
- Have measurable or evaluable disease based on specific medical criteria.
- Have had no more than three prior treatment regimens.
- Have not received certain types of cancer treatments before, such as anti-angiogenic agents or PARP inhibitors.
- Be in good overall health with specific blood counts and organ function levels.
- Be able to swallow and retain oral medications.
- Be 18 years or older.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a period after treatment.
Exclusion Criteria
- Have received chemotherapy or radiotherapy within a certain period before starting the study.
- Have used other investigational agents recently.
- Have had prior treatments affecting specific cancer pathways.
- Have only CA-125 disease without measurable or evaluable disease.
- Have certain medical conditions, such as bowel obstruction or recent major surgery.
- Have untreated or symptomatic brain metastases.
- Have significant heart or vascular disease.
- Have a history of other cancers unless treated and in remission for a specified period.
- Be pregnant or breastfeeding.
- Be taking medications that interact with the study drugs.
- Have uncontrolled illnesses that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Sutter Auburn Faith Hospital | 95602 | Auburn | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
| Mercy San Juan Medical Center | 95608 | Carmichael | California |
| Mercy Cancer Center - Elk Grove | 95758 | Elk Grove | California |
| Marin Cancer Care Inc | 94904 | Greenbrae | California |
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
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