Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002933
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
CWRU 1296 Biochemical and Pharmacokinetic Predictors of Colon Cancer Response to a Topoisomerase I Directed Treatment With Irinotecan
Status:
COMPLETED
Status Verified Date:
2020-07
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 irinotecan in treating patients who have metastatic or recurrent colorectal cancer
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent colorectal cancer
Detailed Description:
OBJECTIVES I Confirm the greater than 20 response rate to irinotecan in patients with metastatic or recurrent colorectal cancer who have not receive prior chemotherapy for their advanced disease II Characterize pharmacokinetic parameters of irinotecan and its metabolite SN-38 and their relationship to response and toxic effect III Characterize tumor samples for topoisomerase I activity proliferative fraction ki67 expression and p53 expression and determine whether clinical response is related to these tumor characteristics in patient population IV Determine the in vitro inhibition of topoisomerase I activity by irinotecan SN-38 and other camptothecin analogs and evaluate whether the degree of in vitro sensitivity to irinotecan andor SN-38 is associated with clinical response in these patients VII Determine the frequency of somatic mutations following irinotecan and correlate this with pharmacologic parameters
OUTLINE Patients receive irinotecan IV at a starting dose weekly for 4 weeks followed by 2 weeks of rest Treatment continues in the absence of disease progression or unacceptable toxicity Tumor status is reassessed every 12 weeks during study Patients attaining a complete response may receive additional courses of treatment Patients are followed until death
PROJECTED ACCRUAL A total of 54 patients will be accrued into this study at a rate of 25 patients per year
OUTLINE Patients receive irinotecan IV at a starting dose weekly for 4 weeks followed by 2 weeks of rest Treatment continues in the absence of disease progression or unacceptable toxicity Tumor status is reassessed every 12 weeks during study Patients attaining a complete response may receive additional courses of treatment Patients are followed until death
PROJECTED ACCRUAL A total of 54 patients will be accrued into this study at a rate of 25 patients per year
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