Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193284
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 22, 2010
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC

Brief Summary:
Although gefitinib has been combined successfully with various chemotherapeutic regimens with minimal increase in overall toxicity, experience with concurrent radiation therapy is limited. In this trial, we will evaluate the feasibility, toxicity, and effectiveness a novel combination of chemotherapy, radiation therapy, and gefitinib.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Gefitinib Drug: Docetaxel Drug: Carboplatin Drug: Fluorouracil Phase 2

Detailed Description:

Upon determination of eligibility, patients will receive:

Induction Therapy

  • Docetaxel
  • Carboplatin
  • 5-FU
  • Gefitinib

Combined Modality Therapy

Cohort 1:

  • Radiation therapy
  • Gefitinib

Cohort 2:

  • Radiation therapy
  • Gefitinib
  • Docetaxel

Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Induction Chemotherapy Plus Gefitinib (Iressa) Followed by Concurrent Chemotherapy, Radiation Therapy, and Gefitinib (Iressa) For Patients With Locally Advanced Squamous Carcinoma of the Head and Neck
Study Start Date : October 2003
Actual Primary Completion Date : February 2006
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources

Primary Outcome Measures :
  1. Overall response rate

Secondary Outcome Measures :
  1. Overall survival
  2. Time to progression
  3. Overall toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Squamous carcinoma of the head and neck.
  • Primary tumor nasopharynx, oral cavity, oropharynx, hypopharynx, and larynx
  • Squamous carcinoma in cervical nodes no identified primary site
  • Must be considered to have low cure rates with local therapy
  • Previously untreated with chemotherapy or radiation therapy.
  • Able to perform activities of daily living without assistance
  • Adequate bone marrow, liver, and kidney function
  • Mild peripheral neuropathy is allowed
  • Measurable or evaluable disease
  • Voluntarily give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Age < 18 years
  • History of prior malignancy within the last five years
  • Severe or uncontrolled systemic disease
  • Significant clinical disorder or laboratory finding
  • Women who are pregnant or breast-feeding
  • Active interstitial lung disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193284

United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results: Identifier: NCT00193284     History of Changes
Other Study ID Numbers: SCRI HN 04
IIT 15038
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: January 2009

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors