Erlotinib and Bevacizumab in Treating Patients With Stage IV Melanoma
NCT00466687 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2013-07-22
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.
Conditions
Interventions
- BIOLOGICAL
-
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
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Vanderbilt-Ingram Cancer Center
lead OTHER
Principal Investigators
-
Jeffrey A. Sosman, MD · Vanderbilt-Ingram Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-30
- Primary Completion
- 2008-08-31
- Completion
- 2008-09-30
Countries
- United States
Study Locations
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