A RANDOMIZED PHASE III EVALUATION OF PACLITAXEL + G-CSF + CISPLATIN VERSUS CISPLATIN + 5-FU IN ADVANCED HEAD AND NECK CANCER

Fecha de inicio: 1 de marzo de 1997

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and neck considered incurable by surgery or radiotherapy Newly diagnosed extensive locoregional disease or distant metastases Locoregionally recurrent or persistent disease, or distant metastases occurring after initial surgery or radiotherapy No nasopharyngeal carcinoma No history of brain metastases Measurable or evaluable disease Documented progressive disease or biopsy-proven residual carcinoma required if sole measurable site previously irradiated PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: ANC at least 1,500/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT no greater than twice normal Alkaline phosphatase no greater than twice normal Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine clearance at least 50 mL/min Calcium normal No history of hypercalcemia Cardiovascular: No congestive heart failure No serious arrhythmia requiring medication No myocardial infarction within 6 months No medications known to alter cardiac conduction (i.e., lanoxin, beta or calcium channel blockers) Other: No significant detectable or occult infection Complete evaluation required if elevated WBC (12,000 or greater) or fever (101.6 F or higher) No hypersensitivity to E. coli-derived proteins No allergy to drugs utilizing Cremophor No other malignancy within 3 years except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test Fertile patients must use effective contraception Must complete quality of life and pain assessments at required intervals PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for recurrent disease At least 12 months since induction or neoadjuvant chemotherapy with paclitaxel or fluorouracil (6 months since cisplatin) Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Recovered from major surgery