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

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Lilly

Status and phase

Completed
Phase 3

Conditions

Mesothelioma

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00190762
5362
H3E-MC-JMEW

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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