Methotrexate Compared With Paclitaxel in Treating Patients With Advanced Head and Neck Cancer

• Status: Completed
• Trial end date: 2004-03-02
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate or paclitaxel is more effective in treating patients with advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of methotrexate with that of paclitaxel in treating patients who have advanced head and neck cancer that cannot be treated with cisplatin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Methotrexate; Paclitaxel

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