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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: Fluorouracil

Drug: Docetaxel

Drug: Carboplatin

Drug: Gefitinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193284

IIT 15038

SCRI HN 04

IRUSIRES0047

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.