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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2009-01-31

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.

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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

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gefitinib

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Fluorouracil

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No