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

OBJECTIVES: I. Evaluate the response rate of patients with stage IIIB or IV nonsmall cell
lung cancer to different schedules of docetaxel and gemcitabine therapy. II. Evaluate the
toxicity of this treatment in these patients. III. Describe the quality of life parameters
of patients receiving this combination therapy. IV. Determine the survival rate of these
patients.

OUTLINE: This is a randomized study. Patients are stratified by disease (stage IIIB vs stage
IV) and performance status (0 vs 1). Patients are randomized to one of two treatment arms
(Arm I now closed). Arm I: Patients receive docetaxel IV over 1 hour on day 1 followed by
gemcitabine IV over 30 minutes on days 1, 8, and 15. (closed as of 8/31/1999) Arm II:
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and
15. Arm III: Patients receive docetaxel IV on day 1 and gemcitabine IV on days 1, 8, and 15.
Patients continue treatment every 28 days for a maximum of 6 courses in the absence of
unacceptable toxicity or disease progression. Patients with either stable disease or
complete/partial response who discontinue treatment after 4-6 courses may be eligible for
NCCTG-97-24-51. Quality of life is assessed before treatment and before each course of
therapy. Patients are followed every 3 months for 1 year, then every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 19-53 patients will be accrued for this study within 6-18
months.

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB/IV nonsmall
cell lung cancer eligible for first line chemotherapy Measurable disease (must be outside
radiation port or proof of progressive disease) Metastatic CNS disease allowed if treated
and stable for at least 21 days prior to study

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at
least 10 g/dL Absolute neutrophil count at least 1500/mm3 Hepatic: Bilirubin no greater
than upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN AST no
greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular:
At least 3 months since prior myocardial infarction No uncontrolled congestive heart
failure No uncontrolled arrhythmias Other: Not pregnant or nursing Fertile patients must
use effective contraception Peripheral neuropathy less than grade 2 No history of
hypersensitivity to products containing polysorbate 80 No other significant medical
condition No meningeal carcinomatosis No weight loss of greater than 10% within past 3
months due to disease

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy to pelvis, spine, or long bones and recovered No prior radiotherapy to at
least 30% of bone marrow Surgery: Greater than 4 weeks since prior major surgery Other: At
least 3 weeks since prior investigational drugs