Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma

Phase 1

Completed

• Conditions: Malignant Pleural Mesotherioma

• Registration Number: NCT00251550
• Lead Sponsor: Eli Lilly and Company

Brief Summary

To investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive patients with Malignant Pleural Mesothelioma.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-11-08
• Study First Submitted QC: 2005-11-08
• Study First Posted: 2005-11-10
• Study Completion: 2006-08
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-05
• Last Update Posted: 2007-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Inapplicable for radical operation
• Not received prior systemic chemotherapy
• Performance status: 0-1

Exclusion Criteria

• Having a history of sensitivity to platinum agent, folic acid or vitamin B12

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the recommended dose of LY231514 and cisplatin combination therapy, Response Rate

Secondary Outcome Measures

Name	Time	Method
QOL
Duration of response
Progression free survival
Median survival time
1 year survival rate
Pulmonary function
Safety
Plasma concentration

Trial Locations

Locations (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 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician; 🇯🇵 Tokyo, Japan