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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00626405 |
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.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: bevacizumab Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Drug: temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
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 |
Estimated Enrollment: | 41 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90 minutes on days 1 and 15.
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Drug: bevacizumab
Given IV over 30-90 minutes
Drug: temozolomide
Oral temozolomide on days 1-5
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Arm II: Experimental
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.
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Drug: bevacizumab
Given IV over 30-90 minutes
Drug: carboplatin
Given IV over 30 minutes
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV over 30 minutes
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OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1 vs 2) 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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologic confirmed diagnosis of malignant melanoma
Measurable disease with at least one lesion whose longest diameter can be measured as ≥ 20 mm by CT or MRI scans OR ≥ 10 mm by spiral CT
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Study Chair: | Svetomir Markovic, MD, PhD | Mayo Clinic |
Study ID Numbers: | CDR0000587708, NCCTG-N0775 |
Study First Received: | February 28, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00626405 |
Health Authority: | Unspecified |
stage IV melanoma |
Neuroectodermal Tumors Paclitaxel Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Carboplatin |
Bevacizumab Nevus Temozolomide Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Therapeutic Uses Tubulin Modulators Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents |