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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2005-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Mesothelioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pemetrexed

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No