Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer

OBJECTIVES:

• Compare overall survival, response rate, and time to progression of patients with non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine and cisplatin.
• Compare the toxicities of each of these 2 regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the past 6 months (less than 5% vs at least 5%) and disease stage (stage IIIB with pleural or pericardial effusion or pleural implants vs stage IV/recurrent). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1.
• Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 only.

Treatment continues in both arms every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this study within 12 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung carcinoma of any of the following subtypes:

• Squamous cell
• Adenocarcinoma
• Large cell anaplastic
• Bronchioalveolar
• Non-small cell carcinoma not otherwise specified
• No small cell anaplastic elements allowed
• Must have:

• Recurrent disease after prior radiotherapy or surgery OR
• Stage IV disease with distant metastases OR
• Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest x-ray or pleural implants documented pathologically or on CT or chest x-ray
• Bidimensionally measurable or evaluable disease
• Brain metastases allowed provided clinically stable after treatment with surgery and/or radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No uncontrolled high blood pressure, unstable angina, or congestive heart failure
• No myocardial infarction within the past 6 months
• No serious ventricular arrhythmias requiring medication

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other active malignancies requiring ongoing treatment
• No uncontrolled serious active infections
• No suspected hypersensitivity to agents that utilize Cremophor
• No evidence of neuropathy grade 2 or greater by history or physical examination

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for non-small cell lung cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy to only site of measurable or evaluable disease unless subsequent progression documented by physical exam, radiograph, or pathology
• Recovered from prior radiotherapy
• No concurrent radiotherapy except for whole brain radiation for developing brain metastases

Surgery:

• See Disease Characteristics