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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190762
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
Information provided by:
Eli Lilly and Company

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
Mesothelioma Drug: Pemetrexed Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
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 : October 2001
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190762

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Canada, Ontario
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
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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
Layout table for additonal information Identifier: NCT00190762    
Other Study ID Numbers: 5362
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors