Study on Paclitaxel and Carboplatin With or Without Bevacizumab for Treating Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01167712
This clinical trial is testing different schedules of chemotherapy drugs paclitaxel and carboplatin, with or without the addition of bevacizumab, to see which is more effective in treating advanced ovarian, peritoneal, or fallopian tube cancer.
Patient Parameters
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Program Overview
This study is exploring whether giving the chemotherapy drug paclitaxel once a week is more effective than giving it every three weeks when combined with carboplatin, with or without bevacizumab, in treating advanced ovarian, peritoneal, or fallopian tube cancer. Paclitaxel and carboplatin work by stopping cancer cells from growing, while bevacizumab helps by blocking the blood supply that tumors need to grow.
Description
The main goal of this study is to find out if giving paclitaxel weekly can delay the progression of cancer or extend survival compared to giving it every three weeks, when combined with carboplatin, with or without bevacizumab. Researchers will also compare the side effects and quality of life between the two paclitaxel schedules.
The study includes two treatment groups:
- Group 1: Patients receive paclitaxel and carboplatin every three weeks for six cycles.
- Group 2: Patients receive paclitaxel weekly and carboplatin every three weeks for six cycles, with surgery between the third and fourth cycles.
Patients in both groups may also receive bevacizumab starting from the second cycle, depending on their choice before joining the study. After completing the treatment, patients will have regular follow-ups to monitor their health.
The study also aims to understand how genetic factors and changes in tumor blood flow might affect treatment outcomes. However, these parts of the study are no longer collecting new data.
Eligibility Criteria
Inclusion Criteria
- Have advanced ovarian, peritoneal, or fallopian tube cancer that is measurable by scans or surgery.
- Have not received prior treatment for this cancer.
- Be in good overall health with a performance status of 0, 1, or 2.
- Have adequate blood counts and organ function.
- Agree to use effective contraception if of childbearing potential.
- Provide informed consent to participate in the study.
Exclusion Criteria
- Have a different type of ovarian tumor or have received prior treatment for ovarian cancer.
- Have had prior radiation or chemotherapy for abdominal or pelvic tumors.
- Have other serious medical conditions or infections.
- Be pregnant or breastfeeding.
- Have a history of severe allergic reactions to study drugs.
- Have active bleeding or conditions that increase the risk of bleeding.
- Have had recent major surgery or plan to have surgery during the study.
- Have tumors in the liver or lungs that are close to major blood vessels.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| University of South Alabama Mitchell Cancer Institute | 36688 | Mobile | Alabama |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Saint Joseph's Hospital and Medical Center | 85013 | Phoenix | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| University of Arizona Cancer Center-Orange Grove Campus | 85704 | Tucson | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| CHI Saint Vincent Cancer Center Hot Springs | 71913 | Hot Springs | Arkansas |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
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