A Phase I/II Study of Carboplatin and Navelbine for Advanced 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
Primary Purpose: Treatment
Gregory A. Masters, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|