NCT01009515

Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Phase II Trial of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The number of melanoma cases has been steadily increasing over the past few decades. For many patients with metastatic melanoma, there are no effective therapies. The goal of this study is to determine whether a combination drug treatment of carboplatin, paclitaxel and temozolomide is effective in the treatment of metastatic or recurrent melanoma.

Detailed description

Over the past several decades, significant research has been conducted to try to identify active chemotherapeutic agents for the treatment of melanoma. The rationale for combining taxanes and platinum agents is that both have activity in melanoma; in vitro and clinical data suggest synergy between these drugs when used in combination in a wide variety of tumors, including melanoma; and the toxicity profiles of these agents do not overlap. Temozolomide (a drug approved for the treatment of melanoma) has been combined with other drugs, including taxanes and platinums, in previous clinical trials for melanoma. Specifically, a previous phase I study of the combination of temozolomide, paclitaxel, and carboplatin in melanoma showed objective responses. The efficacy of this combination is now being studied in this phase II trial.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Paclitaxel, carboplatin, temozolomide	Combination chemotherapy was administered for up to 6 cycles

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-09-01
• Completion: 2015-06-01
• First posted: 2009-11-06
• Last updated: 2017-10-18
• Results posted: 2015-11-03

Locations

3 sites across 1 country: United States