A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190762
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007

September 12, 2005
January 24, 2007
October 2001
Not Provided
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
Same as current
Complete list of historical versions of study NCT00190762 on ClinicalTrials.gov Archive Site
  • 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
  • -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
Not Provided
Not Provided
 
A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Mesothelioma
Drug: Pemetrexed
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
November 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00190762
5362, H3E-MC-JMEW
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT-5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP