A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00190762

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 III

MedlinePlus related topics: Cancer Mesothelioma

Drug Information available for: Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

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

Study placed in the following topic categories:

Folic Acid
Pemetrexed
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Neoplasms, Mesothelial
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009