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 combining carboplatin and
vinorelbine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES: I. Determine the feasibility of chemotherapy with carboplatin and vinorelbine in
patients with stage IIIB or IV non-small cell lung cancer. II. Determine the maximum
tolerated dose and dose limiting toxicities of this regimen in these patients. III.
Determine the response rate and survival of these patients after this treatment.
OUTLINE: This is a dose escalation study of vinorelbine. Patients receive carboplatin IV
over 30 minutes followed by vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment
repeats every 21 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6
patients experience dose limiting toxicity. Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study over 6-12
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage IIIB or IV non-small
cell lung cancer
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 8 weeks Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least
1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times
normal SGOT no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 50 mL/min Other: No significant active infection No other
severe medical illness No prior significant symptomatic peripheral neuropathy (grade 2 or
worse) No concurrent neuropathy Not pregnant or nursing Fertile patients must use
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks
since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen No prior
vinorelbine Endocrine therapy: Not specified Radiotherapy: Recovered from any prior
radiotherapy No prior radiotherapy to more than 10% of bone marrow Surgery: At least 2
weeks since prior major surgery and recovered Other: At least 30 days since prior