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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00190762
Collaborator
(none)
240
Enrollment
1
Location
49
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Oct 1, 2001
Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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 []

  2. 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 []

  3. to compare changes in the average symptom burden index between the Pemetrexed/best supportive care and best supportive care arms []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00190762
Other Study ID Numbers:
  • 5362
  • H3E-MC-JMEW
First Posted:
Sep 19, 2005
Last Update Posted:
Jan 26, 2007
Last Verified:
Jan 1, 2007
Additional relevant MeSH terms:
Mesothelioma
Mesothelioma, Malignant
Pemetrexed

Study Results

No Results Posted as of Jan 26, 2007