Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of raltitrexed in treating patients who have malignant mesothelioma that cannot be surgically removed.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study on Tomusex in Malignant Mesothelioma|
|Study Start Date:||November 1999|
|Primary Completion Date:||June 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the therapeutic activity and toxicities of raltitrexed in patients with inoperable malignant mesothelioma. II. Determine the objective response rate and duration of response in patients treated with this regimen.
OUTLINE: This is a multicenter study. Within 2 weeks of staging procedures, patients receive raltitrexed IV over 15 minutes on day 1. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and then every 8 weeks thereafter for survival.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
|Bologna, Italy, I-40139|
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa, Italy, 16132|
|Istituto Nazionale per lo Studio e la Cura dei Tumori|
|Naples, Italy, 80131|
|Universita Degli Studi di Udine|
|Udine, Italy, 33100|
|Antoni van Leeuwenhoekhuis|
|Amsterdam, Netherlands, 1066 CX|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1117 MB|
|Study Chair:||Giuseppe Giaccone, MD, PhD||Free University Medical Center|