Clinical Trial: Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (Alimta) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
Brief Summary: This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored.
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome: Pathological Complete Response [ Time Frame: Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks) ]
Original Primary Outcome:
Current Secondary Outcome:
- The 1 and 2 Year Disease-Free Survival Rate (Percentage) [ Time Frame: 1 year and 2 years ]
- Overall Tumor Response [ Time Frame: baseline to measured progressive disease ]
- Time to Treatment Failure [ Time Frame: baseline to stopping treatment ]
- Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ]
- Overall Survival Time [ Time Frame: baseline to date of death from any cause ]
Original Secondary Outcome:
Information By: Eli Lilly and Company
Dates:
Date Received: July 12, 2004
Date Started: September 2003
Date Completion:
Last Updated: May 1, 2009
Last Verified: May 2009
