A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Matrix Metalloprotease Inhibitor Prinomastat (AG3340) in Combination With Gemcitabine and Cisplatin in Patients Having Advanced Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Locations
- 2
Study Overview
Brief Summary
RATIONALE: Prinomastat may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase III trial to determine the effectiveness of prinomastat plus cisplatin and gemcitabine in treating patients who have metastatic or recurrent non-small cell lung cancer.
Detailed Description
OBJECTIVES: I. Compare the overall survival, progression free survival, symptomatic progression free survival, and one year survival of patients with metastatic or recurrent non-small cell lung cancer treated with prinomastat (AG3340) or placebo in combination with gemcitabine and cisplatin. II. Compare the disease response and duration of response in these patients on these regimens. III. Compare the quality of life of these patients on these regimens. IV. Evaluate the safety of these regimens in these patients.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive oral prinomastat or placebo twice daily beginning on day 1, followed by gemcitabine IV on days 1 and 8 and cisplatin IV on day 1. Courses repeat every 3 weeks.
PROJECTED ACCRUAL: Approximately 420 patients will be accrued for this study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided