Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
Sponsor: NRG Oncology
ClinicalTrials ID:NCT06580314
This study is exploring whether taking the drug olaparib for one year or two years, with or without another drug called bevacizumab, is more effective in treating advanced ovarian cancer with specific genetic mutations.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to compare the effects of taking olaparib for either one year or two years, with or without bevacizumab, in treating stage III or IV ovarian cancer that has certain genetic mutations. Olaparib works by blocking enzymes that help cancer cells grow, while bevacizumab stops the formation of blood vessels that feed tumors. The study aims to find out if one year of olaparib, with or without bevacizumab, is as effective as two years of olaparib in treating this type of cancer.
Description
The main goal of this study is to see if taking olaparib for one year is as effective as taking it for two years in preventing cancer from getting worse. Researchers will also look at overall survival rates and how long patients live without the cancer coming back. They will monitor any side effects, including the risk of developing other blood-related cancers.
Patients will be randomly assigned to one of two groups. In the first group, patients will take olaparib pills twice a day for up to two years. They may also receive bevacizumab through an IV every three weeks for up to one year. In the second group, patients will take olaparib pills twice a day for up to one year and may also receive bevacizumab in the same way as the first group. Throughout the study, patients will have regular blood tests and scans to monitor their health and the cancer's response to treatment.
After finishing the study treatment, patients will have follow-up visits every three months for two years, then every six months for three more years.
Eligibility Criteria
Inclusion Criteria
- Have newly diagnosed stage III or IV ovarian cancer of specific types, such as high-grade serous or endometrioid, with certain genetic changes in BRCA1/2 genes.
- Have undergone surgery to remove as much of the cancer as possible.
- Have completed a first round of chemotherapy with platinum-based drugs, receiving at least four cycles.
- Show no signs of cancer progression after chemotherapy.
- Be between 18 and older.
- Have a good overall health status, with an ECOG performance score of 0 to 2.
- Not be pregnant or breastfeeding.
- Have adequate blood cell counts and organ function, including:
- Neutrophil count of at least 1,500 cells/mm³.
- Platelet count of at least 100,000 cells/mm³.
- Hemoglobin level of at least 9 g/dL.
- Creatinine clearance greater than 30 mL/min.
- Liver enzymes and bilirubin levels within specified limits.
- No history of certain blood disorders or bone marrow transplants.
- No current infections requiring IV antibiotics.
- No gastrointestinal issues that prevent taking oral medication.
- No known allergies to olaparib or its ingredients.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Mercy Hospital Fort Smith | 72903 | Fort Smith | Arkansas |
| CARTI Cancer Center | 72205 | Little Rock | Arkansas |
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