Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT00113347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-02-27

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer.

Conditions

Interventions

DRUG

Erlotinib

Beginning on Day 2 of treatment, 100, 125, or 150 mg by mouth once a day every day while on treatment, except on days docetaxel is received.

DRUG

Docetaxel

15 mg/m\^2 or 20 mg/m\^2 by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.

RADIATION

Radiation Therapy

Radiation therapy to head/neck beginning on day 1 of treatment once daily 5 times per week (Monday through Friday), delivered in 40 fractions.

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY
  • Genentech, Inc.

    collaborator INDUSTRY
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Bonnie S. Glisson, MD · M.D. Anderson 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
2005-04-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

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 NCT00113347 on ClinicalTrials.gov