RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of cisplatin and gemcitabine in treating patients with advanced squamous cell cancer of the head and neck that cannot be surgically removed.

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of gemcitabine used in combination with cisplatin in the treatment of squamous cell carcinoma of the head and neck.

II. Determine the toxicity profile of this combination treatment in these patients.

III. Assess the response rate of treatment in these patients.

PROTOCOL OUTLINE: This is a dose escalation study of gemcitabine.

Patients receive gemcitabine as an IV bolus on day 1 every 2 weeks. Cisplatin is administered on day 1 every 2 weeks.

In the absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of gemcitabine on the same schedule. If 1 of 3 patients in each cohort experiences DLT, an additional 3 patients are enrolled at that same dose level. If 2 of 3 patients experiences DLT in the cohort, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose.

Patients are assessed for response every 2 weeks. Patients may continue treatment for up to 9 months or until disease progression.

PROJECTED ACCRUAL: At least 3 patients will be accrued for phase I and 20-40 patients will be accrued for phase II of this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven stage III or IV squamous cell carcinoma of the head and neck that is surgically unresectable and not curable by radiation therapy; Upper aerodigestive tract only
• Unresectable or recurrent disease following initial therapy with surgery and/or radiation
• Measurable or evaluable disease

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: Not specified
• Radiotherapy: Prior radiation therapy allowed
• Surgery: Prior surgery allowed

--Patient Characteristics--

• Age: Over 18
• Performance status: SWOG 0-2
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Bilirubin no greater than 3 times institutional normal; Transaminases no greater than 3 times institutional normal
• Renal: Creatinine clearance greater than 40 mL/min
• Cardiovascular: Adequate cardiac function; No heart failure
• Pulmonary: Adequate pulmonary function not requiring supplemental oxygen
• Other: Not pregnant; Fertile patients must use adequate contraception