ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial
- Determine the objective tumor response rate in chemotherapy-naïve patients with
malignant pleural mesothelioma treated with pemetrexed disodium and gemcitabine.
- Determine the median survival of patients with malignant pleural or peritoneal
mesothelioma treated with this regimen.
- Determine the time to objective tumor response and duration of response in patients
treated with this regimen.
- Determine the time to treatment failure in patients treated with this regimen.
- Determine the time to progressive disease in patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this
- Determine the quantitative and qualitative toxic effects of this regimen in these
OUTLINE: This is an open-label, multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and pemetrexed disodium IV
over 8-15 minutes on day 8. Treatment repeats every 21 days for at least 6 courses in the
absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months.
PROJECTED ACCRUAL: A total of 18-73 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Afshin Dowlati, MD
Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University||Cleveland, Ohio 44106|