Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00002911
- Lead Sponsor
- ILEX Oncology Services, Incorporated
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (50)
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
Hematology Associates, Ltd.
🇺🇸Phoenix, Arizona, United States
Marin Cancer Institute
🇺🇸Greenbrae, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Scripps Memorial Hospital Stevens Cancer Center
🇺🇸La Jolla, California, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
St. Joseph Hospital - Orange
🇺🇸Orange, California, United States
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
Kaiser Permanente Medical Center - Vallejo
🇺🇸Vallejo, California, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
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