Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma.
Drug: epirubicin hydrochloride
Drug: gemcitabine hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma|
|Study Start Date:||July 2001|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
- Determine the antitumor activity of gemcitabine and epirubicin in patients with malignant pleural mesothelioma.
- Determine the toxicity of this regimen in this patient population.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Assess quality of life in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and epirubicin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR.
Quality of life is assessed at baseline, prior to course 3, at 3 months, and then at 1 year.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 15-41 patients will be accrued for this study within 6-18 months.