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

NCT00190762 | Completed Phase 3

• 2 other identifiers: 5362H3E-MC-JMEW
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesothelioma

Outcome Measures

Primary Outcomes (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 Outcomes (3)

• 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

Interventions

Pemetrexed DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, K1H8L6, Canada

Location

MeSH Terms

Conditions

Mesothelioma

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2001
• Study Completion: November 1, 2005
• Last Updated: January 26, 2007

Record last verified: 2007-01

Locations

CA (1)