Testing the Combination of Cediranib and Olaparib in Recurrent Ovarian Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02345265
This study is exploring how well the drugs olaparib and cediranib work together in treating ovarian, primary peritoneal, or fallopian tube cancer that has returned after initial improvement. These drugs may help stop tumor growth by blocking certain enzymes needed for cell growth.
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Program Overview
This phase II clinical trial is investigating the effectiveness of combining two drugs, olaparib and cediranib maleate, in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement. The study aims to see if these drugs can stop the growth of cancer cells by blocking specific enzymes necessary for cell growth.
Description
The main goals of this study are to see how well the combination of cediranib and olaparib works in women with recurrent ovarian cancer that is sensitive or resistant to platinum-based chemotherapy. Researchers will measure how long patients live without the cancer getting worse and how well the cancer responds to the treatment. They will also look at the safety of the treatment and any side effects.
Secondary goals include understanding how the treatment affects overall survival, the stability of the disease, and the response in different types of ovarian cancer. The study will also explore changes in certain biomarkers and genetic factors that might influence how well the treatment works.
Participants will take olaparib twice a day and cediranib once a day in 28-day cycles. They will also undergo various tests, including tumor biopsies, blood tests, heart scans, and imaging scans like CT or MRI throughout the study. After finishing the treatment, participants will be monitored for 30 days.
The study will also test a mobile app to help collect patient data on blood pressure and symptoms, and assess how easy it is for patients and healthcare providers to use.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed ovarian, peritoneal, or fallopian tube cancer with specific high-grade types or a BRCA mutation.
- Must have measurable disease that can be tracked using standard criteria.
- Must not have used PARP inhibitors before.
- Must not have progressed on prior anti-angiogenic therapy in the initial treatment.
- For platinum-sensitive cancer: cancer must not have worsened within 6 months of last platinum-based treatment.
- For platinum-resistant cancer: cancer must have worsened within 6 months of last platinum-based treatment.
- Must be 18 years or older.
- Must have good overall health with 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 not have conditions that affect drug absorption.
- Must be willing to provide a tumor sample for research and check blood pressure daily.
Exclusion Criteria
- Must not have had chemotherapy or radiation within 3 weeks before starting the study.
- Must not have used other investigational drugs within 4 weeks before the study.
- Must not have uncontrolled high blood pressure or need more than three medications to manage it.
- Must not have a history of severe heart problems or recent heart attack.
- Must not have untreated brain metastases or other serious medical conditions.
- Must not be pregnant or breastfeeding.
- Must not have a history of allergic reactions to similar drugs.
- Must not be taking certain medications that interact with the study drugs.
- Must not have active infections like HIV or hepatitis that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Keck Medical Center of USC Pasadena | 91105 | Pasadena | California |
| Mayo Clinic in Florida | 32224-9980 | Jacksonville | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Johns Hopkins University/Sidney Kimmel Cancer Center | 21287 | Baltimore | Maryland |
| National Institutes of Health Clinical Center | 20892 | Bethesda | Maryland |
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