s0216, combination chemotherapy and rt in treating patients with stage iii or stage iv head and neck cancer

Conditions: Head and Neck Cancer

Summary: rationale: drugs used in chemotherapy use 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. combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage iii or stage iv head and neck cancer.

objectives: * determine the overall survival of patients with stage iii or iv squamous cell head and neck cancer treated with docetaxel, cisplatin, and fluorouracil followed by accelerated fractionation/concomitant boost radiotherapy and cisplatin. * determine the unconfirmed complete response rate in these patients after treatment with induction chemotherapy. * determine the overall complete response rate (confirmed and unconfirmed) in patients treated with this regimen. * determine the toxic effects of this regimen in these patients. outline: * induction chemotherapy: patients receive docetaxel iv over 1 hour and cisplatin iv over 30-60 minutes on day 1 and fluorouracil iv continuously on days 1-4. treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity. * chemoradiotherapy: beginning within 3-4 weeks after administration of the second course of induction chemotherapy, patients receive accelerated fractionation radiotherapy once daily, 5 days per week, for 6 weeks with concomitant boost radiotherapy once daily, 5 days a week, for the last 2.5 weeks of radiotherapy. patients also receive concurrent cisplatin iv over 30-60 minutes on days 1 and 22. patients are followed every 2 months for 1 year, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 1 year. projected accrual: a total of 60 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell carcinoma of the head and neck (excluding lip, nasopharynx, paranasal sinus, and salivary gland) by biopsy or fine needle aspirate of the primary lesion or neck mass * stage iii or iv disease * no evidence of distant metastases * negative chest x-ray * primary site in the head and neck region must be identified * no unknown primary site * considered to be appropriate for definitive radiotherapy with curative intent patient characteristics: age * 18 and over performance status * zubrod 0-1 life expectancy * not specified hematopoietic * granulocyte count greater than 1,500/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic * bilirubin no greater than upper limit of normal (uln) * alkaline phosphatase less than 2 times uln * alt or ast less than 1.5 times uln renal * creatinine less than 1.5 mg/dl cardiovascular * no myocardial infarction within the past 3 months * no unstable or uncontrolled angina other * not pregnant or nursing * fertile patients must use effective contraception * no other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage i or ii cancer currently in complete remission * no evidence of pre-existing peripheral neuropathy * no active systemic infection * no history of hypersensitivity reaction to products containing polysorbate 80 prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy endocrine therapy * not specified radiotherapy * see disease characteristics * no prior radiotherapy surgery * no prior surgery for head or neck cancer

Keywords: stage iii squamous cell carcinoma of the hypopharynx stage iii squamous cell carcinoma of the larynx stage iii squamous cell carcinoma of the oropharynx stage iv squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the larynx stage iv squamous cell carcinoma of the oropharynx