Capecitabine in Treating Patients With Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT00004183|
Recruitment Status : Completed
First Posted : February 25, 2004
Last Update Posted : July 14, 2016
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 capecitabine in treating patients who have malignant mesothelioma.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Mesothelioma||Drug: capecitabine||Phase 2|
OBJECTIVES: I. Determine the response rate, overall survival, and failure free survival of patients with malignant mesothelioma treated with capecitabine. II. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 3 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 7-9 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study|
|Study Start Date :||November 2000|
|Primary Completion Date :||December 2003|
|Study Completion Date :||January 2006|
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 3 months for 2 years and then annually thereafter.
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): NCT00004183
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|Study Chair:||Gregory Otterson, MD||Ohio State Comprehensive Cancer Center|