NCT00466687

Erlotinib and Bevacizumab in Treating Patients With Stage IV Melanoma

A Phase II Trial of Tarceva (Erlotinib) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab	10mg/kg, slow IV infusion, Days 1 and 14
DRUG	erlotinib hydrochloride	150mg PO qd
GENETIC	fluorescence in situ hybridization	Targeting multiple genetic aberrations in isolated tumor cells.
GENETIC	gene expression analysis	gene expression analysis
OTHER	immunologic technique	immunologic technique
OTHER	laboratory biomarker analysis	laboratory biomarker analysis
PROCEDURE	biopsy	biopsy

Timeline

• Start date: 2004-09-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2007-04-27
• Last updated: 2013-07-22
• Results posted: 2013-02-28

Locations

4 sites across 1 country: United States