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
  Purpose

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 Intervention Phase
Mesothelioma
Drug: Pemetrexed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Estimated Enrollment: 240
Study Start Date: October 2001
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190762

Locations
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
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00190762     History of Changes
Other Study ID Numbers: 5362, H3E-MC-JMEW
Study First Received: September 12, 2005
Last Updated: January 24, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 18, 2014