Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Summary
This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel in treating melanoma.
Timeline
- Start
- 2005-06
- Primary completion
- 2011-01
- Completion
- 2012-08
Outcome
Missed primary endpoint
paper Sorafenib does not improve OS when given in combination with CP for chemotherapy-naive patients with metastatic melanoma. PMID 23248256 ↗
registry p = 0.863; Hazard Ratio (HR) 1.01 (95% CI 0.87 to 1.18); Log Rank NCT00110019 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sorafenib | Small molecule | 400 mg | Oral |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Paclitaxel | Small molecule | 225 mg/m2 | Intravenous |