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Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma

Published: May 28, 2003

Primary Outcome Measures:

  • To determine the objective tumor response rate for pemetrexed plus gemcitabine every 21 days in patients with malignant pleural mesothelioma who have not received prior chemotherapy.

Secondary Outcome Measures:

  • To assess time to objective tumor response for responding patients;To assess duration of response for responding patients;To assess time to treatment failure;To assess time to progressive disease
  • To assess progression-free survival;To assess overall survival;To determine toxicities of pemetrexed in combination with gemcitabine in this population

Criteria

Inclusion Criteria
  • Diagnosis of mesothelioma that can be treated with chemotherapy
  • Have received no prior chemotherapy for mesothelioma
  • Have at least one measurable lesion
  • Have an adequate performance status
  • Sign an informed consent
Exclusion Criteria
  • Previous treatment with chemotherapy for mesothelioma
  • Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed
  • Treatment with radiation therapy within the last 4 weeks
  • Brain metastasis that is uncontrolled
  • Active infection or other serious condition
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Quick Facts

Added:
May 28, 2003

Last Updated:
May 28, 2003

Accepts Healthy Volunteers:
No

Ages Eligible for Study:
18 Years and older

ClinicalTrials.gov Identifier:
NCT00061477

Contact:


Estimated Enrollment:
48

Estimated Primary Completion Date:
September 2006

Estimated Study Start Date:


Genders Eligible for Study:
Both

Status: