Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003544
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of Preoperative Irinotecan CPT-11 in Patients With High-Risk Resectable Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 irinotecan in treating patients with metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients with metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Evaluate the clinical usefulness of preoperative irinotecan in patients with high risk technically resectable metastatic colorectal cancer that is refractory to fluorouracil II Evaluate prospectively the relationship between expression of selected molecular determinants of response and clinical responsiveness to irinotecan in these patients III Determine the effect of treatment with irinotecan on the expression of putative response determinants in these patients
OUTLINE This is an open label study Patients receive irinotecan IV over 90 minutes weekly for 4 consecutive weeks Course repeats every 6 weeks After 2 courses CT scan is obtained and patients showing evidence of disease that is still amenable to surgical resection undergo surgery Approximately 4-8 weeks after surgical resection patients receive 3 additional courses of irinotecan in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years and then every 6 months for years 3 and 4
PROJECTED ACCRUAL A total of 30 patients will be accrued into this study
OUTLINE This is an open label study Patients receive irinotecan IV over 90 minutes weekly for 4 consecutive weeks Course repeats every 6 weeks After 2 courses CT scan is obtained and patients showing evidence of disease that is still amenable to surgical resection undergo surgery Approximately 4-8 weeks after surgical resection patients receive 3 additional courses of irinotecan in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years and then every 6 months for years 3 and 4
PROJECTED ACCRUAL A total of 30 patients will be accrued into this study
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 |
|---|---|---|---|
| NCI-G98-1476 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066598 | REGISTRY | None | None |