Back to resultsA Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma
Primary Purpose
Mesothelioma
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Mesothelioma
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- 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
Outcomes
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00190762
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00190762
Brief Title
A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma
Official Title
A Randomized Phase 3 Trial Comparing ALIMTA Plus Best Supportive Care Versus Best Supportive Care Alone in Previously Treated Patients With Locally Advanced or Metastatic Malignant Pleural Mesothelioma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
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 active in second-line mesothelioma in which the standard treatment is best supportive care. This study will compare survival of previously treated patients with malignant pleural mesothelioma who receive Pemetrexed plus best supportive care to the survival of similar patients who receive best supportive care alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
to compare changes in the average symptom burden index between the Pemetrexed/best supportive care and best supportive care arms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT-5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma
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