Erlotinib and Bevacizumab in Treating Patients With Stage IV Melanoma

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00466687
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Apr 27, 2007
Start date
Sep 30, 2004
Status verified
Jul 2013
Primary completion
Aug 31, 2008
Completion
Sep 30, 2008

Study Design

Enrollment
34 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Therapeutic Intervention
    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

Primary Outcome Measure

Number of Patients With Response [ Time Frame: At 6 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research InstituteNashvilleTennessee37203-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6838-
Vanderbilt-Ingram Cancer Center - Cool SpringsNashvilleTennessee37067-1631-
Vanderbilt-Ingram Cancer Center at FranklinNashvilleTennessee37067-

Find similar trials in Nashville, TN

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Sarah Cannon Research Institute· Nashville, TNVanderbilt-Ingram Cancer Center· Nashville, TNVanderbilt-Ingram Cancer Center - Cool Springs· Nashville, TNVanderbilt-Ingram Cancer Center at Franklin· Nashville, TN

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