Carboplatin Plus Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
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.
|Lung Cancer||Drug: carboplatin Drug: vinorelbine ditartrate||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I/II Study of Carboplatin and Navelbine for Advanced Non-Small Cell Lung Cancer|
|Study Start Date:||August 1999|
|Study Completion Date:||March 2002|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004096
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|Study Chair:||Gregory A. Masters, MD||Robert H. Lurie Cancer Center|