Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

OBJECTIVES: I. Compare the complete and overall response rate to gemcitabine and docetaxel
versus gemcitabine and irinotecan in chemotherapy naive patients with stage IIIB or IV
non-small cell lung cancer. II. Compare the overall and failure free survival, duration of
response, and toxicity associated with these combination regimens in this patient
population.

OUTLINE: This is a randomized study. Patients are stratified according to disease stage
(stage IIIB vs stage IV without CNS involvement vs stage IV with CNS involvement vs
recurrent/progressive disease post surgery and/or radiotherapy). Patients are randomized to
one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes
immediately followed by irinotecan IV over 90 minutes on days 1 and 8. Arm II: Patients
receive gemcitabine IV over 30 minutes immediately followed by docetaxel IV over 60 minutes
on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity. Patients achieving partial or complete response or stable disease
receive treatment for least 6 courses and for 2 additional courses beyond the maximum
response, and then at the investigator's discretion. Patients are followed every 3 months
for 1 year, every 6 months for 2 years, and then annually thereafter until disease
progression or death.

PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this
study within 12 months.

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB, IV, or
recurrent non-small cell lung cancer (NSCLC) including: Squamous cell carcinoma
Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic carcinoma (including
giant and clear cell carcinomas) Stage IIIB eligible for other CALGB protocols consisting
of combined chemotherapy and chest radiotherapy not permitted Malignant pleural effusion
allowed CNS metastases allowed following completion of cranial radiotherapy
Unidimensionally or bidimensionally measurable disease Solid tumor mass or hilar lesion
surrounded by aerated lung Pleural based mass Mediastinal or hilar adenopathy clearly
measurable No bone only disease No pleural or pericardial effusions No irradiated lesions
unless progression is documented following radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Granulocyte 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 2 times
upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN if SGOT is
greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No other
malignancies within the past 5 years except curatively treated basal or squamous cell skin
cancer or carcinoma in situ of the cervix or breast Not pregnant or nursing Fertile
patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior chemotherapy for NSCLC Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy At
least 2 weeks since prior whole brain radiotherapy or stereotactic radiotherapy for CNS
disease Surgery: At least 2 weeks since prior surgery for CNS disease