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A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer
Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells. This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).
Details
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 44 |
| Start date | 2004-08 |
| Completion | 2011-08 |
Conditions
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
Interventions
- Carboplatin
- Paclitaxel
- Sorafenib Tosylate
Primary outcomes
- Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria — after 6 weeks (2 cycles)
Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.
Countries
United States