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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Gefitinib
* Drug: Docetaxel
* Drug: Carboplatin
* Drug: Fluorouracil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|nan|
|Drug: Docetaxel|nan|
|Drug: Carboplatin|nan|
|Drug: Fluorouracil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Time to progression |  |  | 
| Overall toxicity |  |  |