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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 24, 2007

Start Date ^ICMJE

October 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00190762 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

-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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Mesothelioma

Intervention ^ICMJE

Drug: Pemetrexed

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

240

Completion Date

November 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00190762

Other Study ID Numbers ^ICMJE

5362, H3E-MC-JMEW

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

January 2007

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

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