Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of gefitinib when given together with radiation therapy with or without cisplatin in treating patients with stage III or stage IV head and neck cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and radiation therapy with cisplatin may kill more tumor cells

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cisplatin; Gefitinib

Criteria

Inclusion Criteria:

• Histologically confirmed locally advanced squamous cell carcinoma of the head and neck involving the oral cavity, oropharynx, hypopharynx, or supraglotticor glottic larynx

• Unresectable disease

• Medically inoperable resectable disease allowed

• Stage III or IV

• No distant metastases

• Only patients with intermediate stage disease (T1-2, N1-N2a or T3, N0-1) are eligible for radiotherapy alone with gefitinib

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100%

• More than 6 months

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9 g/dL

• Bilirubin normal

• AST and ALT no greater than 2.5 times upper limit of normal

• Creatinine normal

• Creatinine clearance at least 60 mL/min

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Medically suitable to withstand a course of definitive radiotherapy

• No ongoing or active infection

• No other malignancy within the past 3 years except basal cell skin cancer or carcinoma in situ of the cervix

• No prior allergic reactions to compounds of similar chemical or biological composition to gefitinib or other study agents

• No uncontrolled concurrent medical or psychiatric illness or social situation that would preclude study participation

• No prior monoclonal antibodies with potential epidermal growth factor receptor (EGFR) binding therapy

• No prior chemotherapy

• No prior radiotherapy

• No prior surgery except biopsy

• No prior anti-EGFR therapy including prior tyrosine kinase inhibitors

• No concurrent combination anti-retroviral therapy for HIV-positive patients

• No other concurrent investigational agents

• No other concurrent commercial or investigational agents or therapies intended to treat the malignancy