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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
25
Ospedale Bellaria
Bologna, Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy
Universita Degli Studi di Udine
Udine, Italy
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Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands