Sorafenib, Bevacizumab, and Oxaliplatin in Treating Patients With Metastatic Malignant Melanoma

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Melanoma (Skin)

In brief

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Bevacizumab may also stop the growth of malignant melanoma by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with bevacizumab and oxaliplatin may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side-effects and best dose of sorafenib when given together with bevacizumab and oxaliplatin and to see how well it works in treating patients with metastatic malignant melanoma.

Key facts

Study ID

NCT00538005

Run by

San Diego Pacific Oncology & Hematology Associates

People needed

54

Starts

2007-05-01

Last updated by the study team

2014-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status 0-2
• Life expectancy ≥ 3 months
• ANC ≥ 1,200/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min
• Bilirubin ≤ 3.0 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• EKG with no evidence of serious arrhythmia or recent myocardial infarction

You may not qualify if…

• Active infection
• Chronic underlying immunodeficiency disease
• Other serious concurrent illness
• Other forms of cancer within 5 years of initial diagnosis except nonmelanoma skin cancer and cervical cancer
• Congestive heart failure or myocardial infarction within the past 6 months
• PRIOR CONCURRENT THERAPY:
• Inclusion criteria:
• See Disease Characteristics
• At least 6 weeks since prior radiotherapy
• More than 4 weeks since prior surgery
• Prior biologic therapy allowed
• Exclusion criteria:
• Prior cytotoxic agents
• Prior sorafenib tosylate, bevacizumab, or oxaliplatin
• Concurrent biological therapy, except growth factors for anemia, neutropenia, or thrombocytopenia
• Concurrent radiotherapy, chemotherapy, or surgery

Where it is running

• San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas — Encinitas, California, United States (enrolling)

Full record on ClinicalTrials.gov

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