Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003843
Status:
TERMINATED
Last Update Posted:
2015-02-16
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Colorectal Cancer
Sponsor:
California Cancer Consortium
Organization:
California Cancer Consortium
Study Overview
Official Title:
UGT1A1 Polymorphism in Patients With Colorectal Cancer Treated With CPT-11 Irinotecan
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to poor accrual
Has Expanded Access:
No
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 colorectal cancer
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have colorectal cancer
Detailed Description:
OBJECTIVES
Determine the frequency of genetic polymorphisms of UGT1 in Hispanics with colorectal cancer
Determine if pharmacokinetics of irinotecan and its metabolites SN38 and SN38G are associated with the genotype of UGT1 and clinical toxicity
Determine whether the genetic polymorphisms of UGT1 are associated with clinical toxicity and pharmacokineticspharmacodynamics of irinotecan in patients with unresectable colorectal cancer treated with irinotecan
Determine the response time to progression and survival in patients with UGT1A1 polymorphisms treated with irinotecan
OUTLINE Genomic DNA is isolated from blood samples from patients and analyzed for UGT1 polymorphisms Patients are stratified according to UGT1 genotype homozygous for wild type vs heterozygous for abnormal allele vs homozygous for abnormal allele
Patients receive irinotecan over 90 minutes weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 28 patients will be accrued for this study
Determine the frequency of genetic polymorphisms of UGT1 in Hispanics with colorectal cancer
Determine if pharmacokinetics of irinotecan and its metabolites SN38 and SN38G are associated with the genotype of UGT1 and clinical toxicity
Determine whether the genetic polymorphisms of UGT1 are associated with clinical toxicity and pharmacokineticspharmacodynamics of irinotecan in patients with unresectable colorectal cancer treated with irinotecan
Determine the response time to progression and survival in patients with UGT1A1 polymorphisms treated with irinotecan
OUTLINE Genomic DNA is isolated from blood samples from patients and analyzed for UGT1 polymorphisms Patients are stratified according to UGT1 genotype homozygous for wild type vs heterozygous for abnormal allele vs homozygous for abnormal allele
Patients receive irinotecan over 90 minutes weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL Approximately 28 patients will be accrued for 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-G99-1513 | None | None | None |
| LAC-USC-3C981 | None | None | None |