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

Tracking Information
First Received DateSeptember 12, 2005
Last Changed DateJanuary 24, 2007
Start DateOctober 2001
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

Descriptive Information
PhasePhase 3
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Drug: Pemetrexed
Recruitment Information
Recruitment StatusCompleted
Enrollment240
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility 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

Administrative Information
NCTIDNCT00190762
SponsorEli Lilly and Company
Verification DateJanuary 2007
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