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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190762

Enrollment

240

Registered

2005-09-19

Start date

2001-10-31

Completion date

2005-11-30

Last updated

2007-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mesothelioma

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.

Interventions

DRUGPemetrexed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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 changes in the average symptom burden index between the Pemetrexed/best supportive care and best supportive care arms	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026