Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer (NCT00565851)
A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865)
🩺 Plain-English Summary (8th-Grade Level)
This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (29 items).
Location: Anchorage Associates in Radiation Medicine — Anchorage, Alaska
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen)
- Patients receiving concurrent immunotherapy, or radiotherapy
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded
- Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded
- Patients with a prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and who subsequently developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible provided that they meet the criteria listed above
- Patients who require parenteral hydration or nutrition and have evidence of partial bowel obstruction or perforation
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor (other than ovarian, fallopian tube, and primary peritoneal) are excluded
- Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
- Patients with uncontrolled infection
- Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
- Patients with \>= grade 2 peripheral neuropathy
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (709 Sites)
Showing the first 25 of 709 sites.
- Anchorage Associates in Radiation Medicine — Anchorage, Alaska
- Anchorage Radiation Therapy Center — Anchorage, Alaska
- Alaska Breast Care and Surgery LLC — Anchorage, Alaska
- Alaska Oncology and Hematology LLC — Anchorage, Alaska
- Alaska Regional Hospital — Anchorage, Alaska
- Alaska Women's Cancer Care — Anchorage, Alaska
- Anchorage Oncology Centre — Anchorage, Alaska
- Katmai Oncology Group — Anchorage, Alaska
- Providence Alaska Medical Center — Anchorage, Alaska
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas
- Sutter Auburn Faith Hospital — Auburn, California
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
- Mills-Peninsula Medical Center — Burlingame, California
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California
- John Muir Medical Center-Concord — Concord, California
- Sutter Davis Hospital — Davis, California
- UC San Diego Moores Cancer Center — La Jolla, California
- Long Beach Memorial Medical Center-Todd Cancer Institute — Long Beach, California
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California
- Memorial Medical Center — Modesto, California
- Palo Alto Medical Foundation-Camino Division — Mountain View, California
- Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.