Conditions: Melanoma
Keywords: stage IV melanoma recurrent melanoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 34
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Tarceva and Avastin:

* Tarceva: 150mg PO, days 1-28
* Avastin: 10mg/kg, IV infusion, days 1,15 Regimen will be repeated every 28 days = 1 course

Interventions: intervention 1: bevacizumab intervention 2: erlotinib hydrochloride intervention 3: fluorescence in situ hybridization intervention 4: gene expression analysis intervention 5: immunologic technique intervention 6: laboratory biomarker analysis intervention 7: biopsy
Intervention descriptions: intervention 1: 10mg/kg, slow IV infusion, Days 1 and 14 intervention 2: 150mg PO qd intervention 3: Targeting multiple genetic aberrations in isolated tumor cells. intervention 4: gene expression analysis intervention 5: immunologic technique intervention 6: laboratory biomarker analysis intervention 7: biopsy

Protocol document: