CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
bevacizumab +6 morebiological
Likely dose
bevacizumab 10mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00466687
NCT00466687Phase 2Completed

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

Vanderbilt-Ingram Cancer Center·interventional·Posted Apr 27, 2007·Updated Jul 22, 2013

In Brief

A Phase 2 clinical trial evaluating bevacizumab, erlotinib hydrochloride, and 5 other interventions for Melanoma. Completed, enrolled 34 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 27, 2007
Enrollment StartSep 1, 2004
Primary CompletionAug 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 19.2 years ago

Interventions

bevacizumabbiological

10mg/kg, slow IV infusion, Days 1 and 14

erlotinib hydrochloridedrug

150mg PO qd

fluorescence in situ hybridizationgenetic

Targeting multiple genetic aberrations in isolated tumor cells.

gene expression analysisgenetic

gene expression analysis

immunologic techniqueother

immunologic technique

laboratory biomarker analysisother

laboratory biomarker analysis

biopsyprocedure

biopsy