Clinical trial NCT00626405
Conditions: Melanoma (Skin)
Keywords: stage IV melanoma
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2008-08-01; Completion date: 2012-11-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
OBJECTIVES:

Primary

* To assess the anti-tumor activity, in terms of the percentage of patients who are treated with these regimens and who are progression-free at 6 months.
* To assess the safety profile of each treatment regimen.

Secondary

* To estimate the response rate in patients treated with these regimens.
* To estimate the distribution of progression-free survival time and overall survival time of patients treated with these regimens.

Tertiary

* To examine the impact of therapy on angiogenesis and immune homeostasis.

OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1) and location of metastatic disease (M1a \[skin or subcutaneous tissue or lymph node only\] vs M1b \[lung\] vs M1c \[other visceral sites\]) and randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15. (closed to accrual 8/21/09)
* Arm II: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.

In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for VEGF plasma levels and analysis of changes in immune homeostasis.

Beginning at study entry, patients are followed up every 3 months for 2 years and then every 6 months for up to 3 years.

Arms: arm 1: Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15. arm 2: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15, and carboplatin IV over 30 minutes on day 1.
Interventions: intervention 1: bevacizumab intervention 2: carboplatin intervention 3: paclitaxel albumin-stabilized nanoparticle formulation intervention 4: temozolomide
Intervention descriptions: intervention 1: Given IV over 30-90 minutes intervention 2: Given IV over 30 minutes intervention 3: Given IV over 30 minutes intervention 4: Oral temozolomide on days 1-5

Protocol documents: