Condition
Mesothelioma
Estimated Enrollment: 240
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: 5362|H3E-MC-JMEW
Study First Received: September 12, 2005
Last Updated: January 24, 2007
Estimated Primary Completion Date: null
Primary Outcome Measures:
The primary objective of this study is to compare the overall survival following treatment with Pemetrexed plus best supportive care versus best supportive care alone|To characterize and compare the toxicities of Pemetrexed/best supportive care and best supportive care alone in this patient population;to determine the objective-tumor response rate|to compare time to event efficacy variables of both arms including:duration of response,time to objective tumor response,time to treatment failure,time to documented disease progression,progression-free survival|to compare changes in the average symptom burden index between the Pemetrexed/best supportive care and best supportive care arms
Sponsors and Collaborators:
Eli Lilly and Company
Website Link: https://ClinicalTrials.gov/show/NCT00190762
