Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Study of Temozolomide Versus Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin in Combination With Bevacizumab in Patients With Unresectable Stage IV Malignant Melanoma

Basic Trial Information

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No brain metastases
• No previous bevacizumab, VEGF-trap, anti-VEGFR monoclonal antibody, sunitinib, or sorafenib
• More than 4 weeks since surgery or open biopsy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive temozolomide by mouth for 5 days in week 1. They will also receive a 30- to 90-minute infusion of bevacizumab in weeks 1 and 3. (closed to accrual 8/21/09)

Patients in group two will receive a 30- to 90-minute infusion of bevacizumab in weeks 1 and 3. They will also receive an infusion of paclitaxel albumin-stabilized nanoparticle formulation once a week in weeks 1-3 and an infusion of carboplatin in week 1.

Treatment in both groups may repeat every 4 weeks for as long as benefit is shown.

Patients will undergo blood sample collection periodically for laboratory studies.

After study entry, patients are evaluated every 3 months for 2 years and then every 6 months for up to 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Svetomir Markovic, MD, PhD, Protocol chair		Ph: 507-284-1370

Registry Information
Official Title		A Randomized Phase II Trial of Temozolomide (TMZ) and Bevacizumab or ABI-007 (ABX)/Carboplatin (CBDCA) and Bevacizumab in Patients with Unresectable Stage IV Malignant Melanoma
Trial Start Date		2008-08-15
Trial Completion Date		2009-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00626405
Date Submitted to PDQ		2008-02-13
Information Last Verified		2009-12-23
NCI Grant/Contract Number		CA25224

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