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

This study has been completed.
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC Identifier:
First received: September 12, 2005
Last updated: June 18, 2010
Last verified: January 2009
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:

Further study details as provided by SCRI Development Innovations, LLC:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Publications: 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
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on February 09, 2016