Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004254|
Recruitment Status : Completed
First Posted : April 23, 2004
Last Update Posted : July 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Drug: raltitrexed||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Official Title:||Phase II Study on Tomusex in Malignant Mesothelioma|
|Study Start Date :||November 1999|
|Actual Primary Completion Date :||June 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004254
|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|