drugset / Trial / NCT00626405

Bevacizumab and Temozolomide or Bevacizumab and Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Treating Patients With Stage IV Malignant Melanoma That Cannot Be Removed by Surgery

NCT00626405 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, paclitaxel albumin-stabilized nanoparticle formulation, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether bevacizumab is more effective when given together with temozolomide or paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in killing malignant melanoma cells. PURPOSE: This randomized phase II trial is studying the side effects of giving temozolomide together with bevacizumab and to see how well it works compared with giving bevacizumab together with paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in treating patients with stage IV malignant melanoma that cannot be removed by surgery.

Timeline

Start
2008-08
Primary completion
2010-07
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Carboplatin Small molecule 6 unknown Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Temozolomide Small molecule 200 mg/m2 Oral

Indications