Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with docetaxel may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells. Phase I trial to study the maximum tolerated dose (MTD) of combining erlotinib with docetaxel and radiation therapy in treating patients who have locally advanced head and neck cancer

Conditions

• Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
• Stage III Squamous Cell Carcinoma of the Hypopharynx
• Stage III Squamous Cell Carcinoma of the Larynx
• Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage III Squamous Cell Carcinoma of the Nasopharynx
• Stage III Squamous Cell Carcinoma of the Oropharynx
• Stage III Verrucous Carcinoma of the Larynx
• Stage III Verrucous Carcinoma of the Oral Cavity
• Stage IV Squamous Cell Carcinoma of the Hypopharynx
• Stage IV Squamous Cell Carcinoma of the Nasopharynx
• Stage IVA Squamous Cell Carcinoma of the Larynx
• Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IVA Squamous Cell Carcinoma of the Oropharynx
• Stage IVA Verrucous Carcinoma of the Larynx
• Stage IVA Verrucous Carcinoma of the Oral Cavity
• Stage IVB Squamous Cell Carcinoma of the Larynx
• Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IVB Squamous Cell Carcinoma of the Oropharynx
• Stage IVB Verrucous Carcinoma of the Larynx
• Stage IVB Verrucous Carcinoma of the Oral Cavity
• Stage IVC Squamous Cell Carcinoma of the Larynx
• Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IVC Squamous Cell Carcinoma of the Oropharynx
• Stage IVC Verrucous Carcinoma of the Larynx
• Stage IVC Verrucous Carcinoma of the Oral Cavity
• Tongue Cancer
• Untreated Metastatic Squamous Neck Cancer With Occult Primary

Interventions

DRUG

erlotinib hydrochloride

Given orally

DRUG

docetaxel

Given IV

RADIATION

radiation therapy

Undergo radiotherapy

PROCEDURE

therapeutic conventional surgery

Undergo neck dissection

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

pharmacological study

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Panayiotis (Panos) Savvides · Case Western Reserve University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-09-30

Primary Completion

2008-02-29

Completion

2008-02-29

Countries

• United States

Study Locations