Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

NCT00083057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-03-15

No results posted yet for this study

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving gefitinib and paclitaxel together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and paclitaxel when given together with radiation therapy in treating patients with advanced or recurrent squamous cell carcinoma (cancer) of the head and neck.

Conditions

Interventions

DRUG

gefitinib

DRUG

paclitaxel

RADIATION

radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Carter Van Waes, MD, PhD · National Institute on Deafness and Other Communication Disorders (NIDCD)

  • John C. Morris, MD · NCI - Metabolism Branch;MET

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2010-10-31
Completion
2010-11-30

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 NCT00083057 on ClinicalTrials.gov