Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
RATIONALE: Marimastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor.
PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of marimastat in treating patients who have residual stage III non-small cell lung cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A PHASE III, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MARIMASTAT IN PATIENTS WITH MINIMAL DISEASE STAGE III NON-SMALL CELL LUNG CANCER|
|Study Start Date:||December 1996|
|Study Completion Date:||May 2004|
OBJECTIVES: I. Compare the effect of marimastat (a matrix metalloproteinase inhibitor) vs. placebo on overall survival in patients with Stage III non-small cell lung cancer who have minimal residual disease following chemotherapy, radiotherapy, and/or surgery. II. Assess the effect of marimastat on time to disease progression in these patients. III. Assess the safety and tolerability of marimastat in these patients.
OUTLINE: This is a randomized, double-blind study. Patients are randomized no less than 2 and no more than 8 weeks after the last prior treatment modality received. Patients are stratified by participating institution. Patients are randomly assigned to receive either oral marimastat or oral placebo twice daily. Treatment begins within 5 days of minimization and continues for up to 18 months after the last patient is enrolled, unless disease progression or unacceptable toxicity intervenes. Patients deriving benefit at end of study may continue treatment if desired. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 504 patients will be entered over 30 months from approximately 60 centers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002911
Show 50 Study Locations
|Study Chair:||Kathleen Heck, MEd, MBA||ILEX Oncology Services, Incorporated|