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

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Aventis Pharmaceuticals
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193284
First received: September 12, 2005
Last updated: June 18, 2010
Last verified: January 2009
History of Changes
  Purpose

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 Intervention Phase
Head and Neck Cancer
 Drug: Gefitinib
Drug: Docetaxel
Drug: Carboplatin
Drug: Fluorouracil
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:
  • Overall response rate

Secondary Outcome Measures:
  • Overall survival
  • Time to progression
  • Overall toxicity

Estimated Enrollment: 50
Study Start Date: October 2003
Study Completion Date: January 2009
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193284

Locations
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
Sarah Cannon Research Institute
AstraZeneca
Aventis Pharmaceuticals
Investigators
Principal Investigator: John D. Hainsworth, MD Sarah Cannon Research Institute
  More Information

Additional Information:
Published article in Cancer  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00193284     History of Changes
Other Study ID Numbers: SCRI HN 04, IRUSIRES0047, IIT 15038
Study First Received: September 12, 2005
Last Updated: June 18, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Fluorouracil
Docetaxel
Gefitinib
Carboplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013