Phase III Randomized Trial of Methotrexate vs. Paclitaxel in Cisplatin-Ineligible Patients With Advanced Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced, incurable, squamous cell
carcinoma of the head and neck Recurrent disease in a previously irradiated field must be
biopsy proven or documented unequivocally by physical exam or radiograph(s) Measurable or
evaluable disease Patients with ECOG performance status of 0-1 must be ineligible for
protocol E-1395 and unable to tolerate cisplatin-based therapy for 1 or more of the
following reasons: Hearing loss that precludes cisplatin Unable to handle a fluid load
necessitated by cisplatin-based treatment, due to underlying cardiac or pulmonary disease
Mild renal insufficiency (creatinine 1.6-2.0 mg/dL) or creatinine clearance of 40-60
mL/min that would make cisplatin treatment difficult, if not dangerous History of brain
metastases allowed if disease has stabilized or improved after radiation and/or craniotomy
No history of carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 (See Disease
Characteristics) Life expectancy: Not specified Hematopoietic: Absolute neutrophil count
at least 1,800/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than
1.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: See Disease
Characteristics Creatinine no greater than 2.0 mg/dL No evidence of symptomatic
hypercalcemia Cardiovascular: See Disease Characteristics No active angina or uncontrolled
arrhythmias Metabolic: No uncontrolled diabetes; no random blood sugar at least 300 mg/dL
Neurological: No evidence of ongoing grade 2 or greater peripheral sensory neuropathy
Pulmonary: See Disease Characteristics Other: No other concurrent, active, invasive
malignancies No significant detectable infection Not pregnant or nursing Effective
contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy except in the adjuvant, neoadjuvant, or radiosensitizing setting No prior
chemotherapy for recurrent or persistent disease after definitive local therapy At least 6
months since prior methotrexate or paclitaxel Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy
Surgery: See Disease Characteristics Recovered from prior surgery