Trials / Completed
CompletedNCT00004254
Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
Phase II Study on Tomusex in Malignant Mesothelioma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | raltitrexed |
Timeline
- Start date
- 1999-11-01
- Primary completion
- 2001-06-01
- First posted
- 2004-04-23
- Last updated
- 2012-07-18
Locations
6 sites across 2 countries: Italy, Netherlands
Source: ClinicalTrials.gov record NCT00004254. Inclusion in this directory is not an endorsement.