Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Conditions

• Head and Neck Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• erlotinib hydrochloride — DRUG
• adjuvant therapy — PROCEDURE

Study Details

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving erlotinib after chemoradiotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of adjuvant erlotinib when given after completing chemoradiotherapy in treating patients with locally advanced squamous cell carcinoma (cancer) of the head and neck.

Key Dates

First listed

Mar 9, 2004

Start date

Mar 2, 2004

Status verified

Apr 2020

Primary completion

Dec 9, 2008

Completion

Jan 18, 2011

Study Design

Enrollment

19 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Primary Outcome Measure

Toxicity/feasibility assessed by NCI CTC v2.0 at the end of course 1

Related Studies

• Identification and Characterization of Novel Proteins and Genes in Head and Neck Cancer
  Recruiting · Stanford University · Stanford, California
• Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers
  Recruiting · Stanford University · Stanford, California
• Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants
  Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee
• Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
  Recruiting · University of Colorado, Denver · Aurora, Colorado