Study on Cediranib Maleate and Olaparib for Treating Recurrent Ovarian, Fallopian Tube, Peritoneal, or Triple-Negative Breast Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01116648
This clinical trial is testing the combination of two drugs, cediranib maleate and olaparib, to see if they work better together than olaparib alone in treating certain types of cancer that have returned after treatment. The study aims to find the best dose and assess the safety and effectiveness of these drugs.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring whether combining two drugs, cediranib maleate and olaparib, can more effectively treat ovarian, fallopian tube, peritoneal, or triple-negative breast cancer that has come back after treatment. Cediranib maleate may help stop cancer cells by affecting their blood supply, while olaparib may prevent cancer cells from growing abnormally. The trial will compare the combination of these drugs to olaparib alone to see which works better.
Description
The study is divided into two phases. In Phase I, researchers will determine the safest dose of cediranib maleate when used with olaparib for treating recurrent ovarian, fallopian tube, or peritoneal cancer, as well as metastatic triple-negative breast cancer. In Phase II, the effectiveness of the drug combination will be compared to olaparib alone in patients with certain types of ovarian, fallopian tube, or peritoneal cancer.
Participants in Phase I will receive both drugs daily for 28-day cycles, with regular health checks and scans to monitor their condition. In Phase II, participants will be randomly assigned to receive either the combination of cediranib and olaparib or olaparib alone, with similar monitoring.
The study will also look at how the drugs affect the body and any side effects they may cause. After completing the treatment, participants will have follow-up visits every six months for up to three years to track their health and any long-term effects.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed ovarian, fallopian tube, peritoneal, or triple-negative breast cancer.
- For Phase II, must have high-grade ovarian, fallopian tube, or peritoneal cancer, or a known BRCA mutation.
- Must have measurable cancer or elevated cancer markers.
- Must have received prior chemotherapy, including a platinum-based regimen.
- Must be at least 18 years old with a life expectancy of more than 6 months.
- Must have good overall health and specific blood counts and organ function.
- Must agree to use effective birth control during and after the study.
- Must be able to take oral medications and monitor blood pressure daily.
Exclusion Criteria
- Cannot have had recent chemotherapy or radiation therapy.
- Cannot be on other investigational drugs or have untreated brain metastases.
- Cannot have allergies to similar drugs or be taking certain medications.
- Cannot have recent heart issues or uncontrolled high blood pressure.
- Cannot have certain other medical conditions or be pregnant or breastfeeding.
- Cannot have HIV or use herbal products during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| NorthShore University HealthSystem-Evanston Hospital | 60201 | Evanston | Illinois |
| Fort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard | 46804 | Fort Wayne | Indiana |
| Fort Wayne Medical Oncology and Hematology Inc-Parkview | 46845 | Fort Wayne | Indiana |
| Johns Hopkins University/Sidney Kimmel Cancer Center | 21287 | Baltimore | Maryland |
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
| National Cancer Institute | 20850 | Rockville | Maryland |
| Massachusetts General Hospital Cancer Center | 02114 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.