Status:
COMPLETED
A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma
Lead Sponsor:
Eli Lilly and Company
Conditions:
Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Based on results from earlier clinical trials, Pemetrexed may have antitumor activity as a first-line agent in the treatment of mesothelioma. Given this, it is hypothesized that Pemetrexed may be acti...
Eligibility Criteria
Inclusion
- Histologically proven diagnosis of mesothelioma of the pleura.
- received only one prior systemic chemotherapy regimen for advanced or metastatic disease
- Performance status of 70 or higher on the Karnofsky Performance Status Scale
- Males or females at least 18 years of age
- Adequate organ function
Exclusion
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- Pregnancy or breastfeeding
- Brain metastasis
- Prior treatment with Pemetrexed
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00190762
Start Date
October 1 2001
End Date
November 1 2005
Last Update
January 26 2007
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9:00 AM - 5:00 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician
Ottawa, Ontario, Canada, K1H8L6