OBJECTIVES:

• Compare the one and two year survival of patients with inoperable advanced non-small cell lung cancer treated with paclitaxel and cisplatin versus standard platinum therapy.
• Compare the toxic effects of these two regimens in this patient population.
• Compare the performance status, tumor response, and quality of life in these patients after these treatment regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, stage of disease (IIIA vs IIIB vs IV), or performance status (ECOG O vs 1 vs 2 vs 3).

Patients are randomized to one of two treatment arms:

• Arm I: Patients receive paclitaxel IV over 3 hours, followed by carboplatin IV over 30 minutes on day 1.
• Arm II: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1 OR mitomycin IV, vinblastine IV, and cisplatin IV over 4 hours on day 1.

Treatment continues every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before each treatment course.

Patients are followed for survival.

PROJECTED ACCRUAL: Approximately 300 patients (150 per treatment arm) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed inoperable advanced non-small cell lung cancer

  • Stage IIIA, IIIB, or IV
  • Not eligible for curative radiotherapy or surgery

• Measurable or evaluable disease

  • No bony lesions as only site of measurable disease
• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2 (ECOG 3 allowed in some cases)

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST or ALT no greater than 3 times ULN (no greater than 5 times ULN for liver metastases)

Renal:

• Creatinine normal OR
• Creatinine clearance at least 60 mL/min

Other:

• Not pregnant
• Fertile patients must use effective contraception during and for 3 months after study
• No active infection
• No other serious systemic disorder that would preclude compliance
• No second malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer
• No peripheral neuropathy, significant neurological disorders (e.g., seizures), or psychiatric disorders

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• Prior radiotherapy allowed if measurable disease outside of irradiated field

Surgery:

• See Disease Characteristics