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

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Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed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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