Melanoma Clinical Trial
Official title:
A Phase II Trial of Tarceva (Erlotinib) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Melanoma
RATIONALE: Erlotinib 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 tumor cells by blocking blood flow to the tumor. Giving erlotinib
together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab
works in treating patients with stage IV melanoma.
OBJECTIVES:
Primary
- Determine the overall response rate, response duration, and frequency of
progression-free survival at 6 months in patients with stage IV melanoma treated with
erlotinib hydrochloride and bevacizumab.
- Determine objective responses in patients treated with this regimen.
Secondary
- Determine the overall safety and tolerability of this regimen in these patients.
- Evaluate tissue blocks for EGFR by monoclonal antibody H11 (DAKO) or fluorescence in
situ hybridization(FISH)7p12-specific probe-overexpression or amplification in patients
treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily on days 1-28 and bevacizumab IV
over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of
disease progression or unacceptable toxicity.
Patients undergo tissue collection to analyze EGFR by monoclonal antibody H11 (DAKO) or
fluorescence in situ hybridization (FISH) 7p12-specific probe-overexpression or
amplification. Biological markers AKT, MAPK, p27, p21, CD13, CD34, and factor VIII are also
measured.
After completion of study treatment, patients are followed periodically.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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