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

This study has been completed.

First Received: September 12, 2005 Last Updated: January 15, 2009 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute AstraZeneca Aventis Pharmaceuticals
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193284

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 II

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Fluorouracil Carboplatin Docetaxel ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

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

No publications provided

Study ID Numbers:	SCRI HN 04, IRUSIRES0047, IIT 15038
Study First Received:	September 12, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00193284 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Carboplatin
Squamous Cell Carcinoma
Immunosuppressive Agents
Protein Kinase Inhibitors
Carcinoma

Docetaxel
Head and Neck Neoplasms
Fluorouracil
Epidermoid Carcinoma
Carcinoma, Squamous Cell
Gefitinib

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Carboplatin
Protein Kinase Inhibitors

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Fluorouracil
Therapeutic Uses
Gefitinib

ClinicalTrials.gov processed this record on May 07, 2009