Melanoma Clinical Trial
Sorafenib, Bevacizumab, and Oxaliplatin in Treating Patients With Metastatic Malignant Melanoma
Summary
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.
Full Description
OBJECTIVES:
To determine the maximum tolerated dose of sorafenib tosylate when administered with bevacizumab and oxaliplatin.
To determine the effect of this treatment regimen on the complete and partial response rate in patients with metastatic melanoma.
To determine the effect of this treatment regimen on the progression-free and overall survival of patients with metastatic melanoma.
OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase II study.
Phase I: Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1. Patients also receive oral sorafenib tosylate twice daily on days 1-14. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Phase II: Patients receive sorafenib tosylate at the maximum tolerated dose and bevacizumab and oxaliplatin as in phase I.
After completion of study therapy, patients are followed for at least 5 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
Metastatic disease
Measurable or evaluable non-CNS disease
Measurable disease, defined as a unidimensionally measurable lesion as determined by physical exam, x-ray, CT scan, MRI, or other radiographic procedure
Evaluable disease, defined as a lesion that can be seen radiographically but is not unidimensionally measurable
Previously irradiated lesions with documented progression are allowed provided there are no other sites of metastatic disease
No active brain metastases
Previously treated, responding brain metastases allowed, provided there is measurable disease outside of the CNS
At least 3 weeks since prior chemotherapy and 6 weeks since prior radiotherapy for CNS disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
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
Exclusion criteria:
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
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There is 1 Location for this study
Encinitas California, 92024, United States More Info
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