Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004183
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2000-01-21
Brief Title:
Capecitabine in Treating Patients With Malignant Mesothelioma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Capecitabine Xeloda in Malignant Mesothelioma A Phase II Study
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 capecitabine in treating patients who have malignant mesothelioma
PURPOSE Phase II trial to study the effectiveness of capecitabine in treating patients who have malignant mesothelioma
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CLB-39807 | None | None | None |
| CDR0000067422 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |