Phase I trial of bortezomib and dacarbazine in melanoma and soft tissue sarcoma.

ABSTRACT:

Purpose

Preclinical studies in human melanoma cell lines and murine xenograft tumor models suggest that the proteasome inhibitor bortezomib enhances the activity of the cytotoxic agent dacarbazine. We performed a phase I trial of bortezomib and dacarbazine in melanoma, soft tissue sarcoma, and amine precursor uptake and decarboxylation tumors. The primary objective was to identify recommended phase II doses for the combination.

Experimental design

Bortezomib and dacarbazine were both administered intravenously once weekly. All patients received prophylactic antiemetics. Dose escalation proceeded using a standard 3 + 3 design. Response was assessed according to NCI RECIST v1.0.

Results

Twenty eight patients were enrolled to six dose levels. Bortezomib 1.6 mg/m(2) and d

SUBMITTER: Poklepovic A 

PROVIDER: S-EPMC3844155 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature