Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma
Recruitment status was Active, not recruiting
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with gemcitabine works in treating patients with pleural or peritoneal malignant mesothelioma.
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial|
|Study Start Date:||February 2003|
- 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 regimen.
- Determine the quantitative and qualitative toxic effects of this regimen in these patients.
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.
|United States, Ohio|
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Afshin Dowlati, MD||Case Comprehensive Cancer Center|