Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin, fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how well they work in treating patients with locally advanced head and neck cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Adelstein
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Fluorouracil; Gefitinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary* squamous cell carcinoma of the head and neck region, excluding any of the following:

• Nasopharynx

• Paranasal sinuses

• Salivary glands NOTE: *Primary site must be identified

• Locoregionally confined stage III or IV disease

• No evidence of nodal disease below the clavicles

• No distant hematogenous metastases (M0)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• WBC > 3,500/mm³

• Platelet count > 100,000/mm³

• Creatinine ≤ 2.0 mg/dL

• Alkaline phosphatase < 2 times normal

• AST < 2 times normal

• Bilirubin ≤ 2.0 mg/dL

• Calcium normal

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Must not be a poor compliance risk for follow-up

• No known severe hypersensitivity to gefitinib or any excipients of this drug

• No evidence of clinically active interstitial lung disease

• Patients with chronic, stable radiographic changes who are asymptomatic are eligible

• No unstable or uncontrolled angina, clinically apparent jaundice, or active infection

• No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ) unless disease free for ≥ 5 years

• No other severe, uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

PRIOR CONCURRENT THERAPY:

• Recovered from prior oncologic or other major surgery

• No prior definitive surgery, radiotherapy, chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for head and neck cancer

• No investigational drugs within the past 30 days

• No concurrent CYP3A4 inducers, including any of the following:

• Phenytoin

• Carbamazepine

• Rifampin

• Phenobarbital

• Hypericum perforatum (St. John's wort)

• Concurrent surgery allowed provided gefitinib is not administered 2 weeks before and 2 weeks after surgery

• No concurrent aminoglycoside antibiotics