Phase I study of the combination of sorafenib and temsirolimus in patients with metastatic melanoma.

ABSTRACT:

Purpose

This phase I clinical trial was conducted to determine the safety, efficacy, and molecular effects of sorafenib with temsirolimus in patients with advanced melanoma.

Patients and methods

Patients with stage IV or unresectable or recurrent stage III melanoma and Eastern Cooperative Oncology Group performance status of 0 to 1 were eligible. Sorafenib was given orally once or twice daily and temsirolimus was given i.v. weekly, both starting on day 1, with a 4-week cycle. Responses were assessed every 2 cycles per Response Evaluation Criteria in Solid Tumors criteria. Consenting patients with accessible tumors underwent optional tumor biopsies before treatment and after the second infusion of temsirolimus. Tumor biopsies were analyzed for activating mutations in BRAF and

SUBMITTER: Davies MA 

PROVIDER: S-EPMC3906678 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature