drugset / Trial / NCT00329641

Sorafenib, Carboplatin, and Paclitaxel in Treating Patients With Stage IV Melanoma of the Eye

NCT00329641 ↗

Phase 2 Completed 25 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial is studying how well sorafenib works when given together with carboplatin and paclitaxel in treating patients with stage IV melanoma of the eye. 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 may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs. Sorafenib may also stop the growth of melanoma by blocking some of the enzymes needed for tumor cell growth and by blocking blood flow to the tumor. Giving sorafenib together with carboplatin and paclitaxel may kill more tumor cells.

Timeline

Start
2011-02
Primary completion
2012-11
Completion
2012-11

Outcome

Missed primary endpoint

paper No confirmed objective responses occurred among the 24 evaluable patients (ORR = 0% [95% CI: 0-14%]) PMID 23226204 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 400 mg Oral
Background Carboplatin Small molecule — Intravenous
Background Paclitaxel Small molecule 225 mg/m2 Intravenous