Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
- Conditions
- Malignant Mesothelioma
- Registration Number
- NCT00004254
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
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
Antoni van Leeuwenhoekhuis
🇳🇱Amsterdam, Netherlands