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Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck

NCT00392665 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-04-13

Study results available
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Summary

The main purpose of this research study is to collect information to learn how effective erlotinib (tarceva) is in combination with either bevacizumab or sulindac in treating patients with squamous cell carcinoma of the head and neck. Erlotinib and bevacizumab are targeted therapy drugs that can control tumor growth by targeting specific abnormalities sometimes found on cancer cells. Erlotinib targets epidermal growth factor receptor (EGFR), and bevacizumab targets vascular endothelial growth factor (VEGF). Sulindac is a non-steroidal anti-inflammatory drug (NSAID) that can block G protein-coupled receptor which laboratory evidence shows is associated with both cancer cell growth and EGFR activity. The bevacizumab being administered in this study is not a commercially marketed formulation of the drug. Previous research with head and neck cancer suggest that erlotinib alone has some anti-cancer activity. This research study is designed to see how well erlotinib works in combination with bevacizumab or sulindac in head and neck cancer.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Interventions

DRUG

Bevacizumab

Given intravenously on day one of each 3 week cycle

DRUG

erlotinib

Given orally once a day

DRUG

Sulindac

Given orally twice a day

Sponsors & Collaborators

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • OSI Pharmaceuticals

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Jochen Lorch, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-08-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00392665 on ClinicalTrials.gov