NCT00087698

Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma

A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (Alimta) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pleural Neoplasms

Interventions

Type	Name	Description
DRUG	pemetrexed	500 mg/m2, intravenous (IV), every 21 days x 4 cycles
DRUG	cisplatin	75 mg/m2, intravenous (IV), every 21 days x 4 cycles

Timeline

• Start date: 2003-09-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2004-07-16
• Last updated: 2009-05-12
• Results posted: 2009-03-17

Locations

7 sites across 1 country: United States