Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving gefitinib and paclitaxel together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and paclitaxel when given together with radiation therapy in treating patients with advanced or recurrent squamous cell carcinoma (cancer) of the head and neck.

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

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Gefitinib; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell (epidermoid) carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or maxillary sinus

• Stage III or IV disease

• Distant metastases allowed provided both of the following are true:

• Metastases are confined to the head and neck region

• Metastases are encompassable in a radiotherapy field with curative intent

• Locally recurrent disease after primary surgery allowed

• Meets 1 of the following criteria:

• Unresectable disease

• Patient prefers chemoradiotherapy over surgery

• Measurable disease

• No brain metastases and/or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3

• Hemoglobin > 10 g/dL

• Platelet count > 100,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

• Bilirubin < 2.0 times upper limit of normal (ULN)

• AST/ALT ≤ 2.5 times ULN

Renal

• Creatinine < 1.5 times ULN OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Pulmonary

• No clinically active interstitial lung disease

• Chronic, stable, asymptomatic radiographic changes allowed

Other

• No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs or Cremophor^® EL

• No AIDS or primary immunodeficiencies

• No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

• Probability of recurrence of the prior malignancy < 5%

• No other concurrent uncontrolled illness

• No ongoing or active serious infection

• No psychiatric illness or situation that would preclude study compliance or giving informed consent

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for cancer

• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior therapeutic radiotherapy to the head and neck region

• No prior radiotherapy for cancer

Surgery

• See Disease Characteristics

• At least 4 weeks since prior major surgery and recovered

Other

• No prior gefitinib or other epidermal growth factor receptor inhibitors

• More than 4 weeks since prior non-approved or investigational agents

• No concurrent administration of any of the following:

• Phenytoin

• Carbamazepine

• Barbiturates

• Rifampin

• Hypericum perforatum (St. John's wort)

• Oxcarbazepine

• Rifapentine

• Amifostine

• Modafinil

• Other CYP3A4 enzyme inducers

• Other anticancer agents or investigational drugs

• Combination antiretroviral therapy for HIV-positive patients