Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048971
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2002-11-12
Brief Title:
Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Pharmacogenetic Case-Control Study of Severe Diarrhea and Life-Threatening Neutropenia in Patients Treated With Irinotecan 5-Fluorouracil and Leucovorin
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 Genetic testing may help predict how patients will respond to chemotherapy drugs and may help doctors plan more effective treatment with fewer side effects
PURPOSE Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy
PURPOSE Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy
Detailed Description:
OBJECTIVES
Determine whether the presence of a 7 allele at the UGT1A1 locus is associated with either grade 3-4 diarrhea or grade 4 neutropenia in patients with stage III colon cancer after treatment with irinotecan fluorouracil and leucovorin calcium
Determine whether polymorphisms in the TS enhancer andor MTHFR gene are associated with grade 3-4 diarrhea in these patients after treatment with fluorouracil and leucovorin calcium
Determine whether polymorphisms in UGT1A1 TS MTHFR CYP3A4 or CYP3A5 are associated with either grade 3-4 diarrhea or grade 4 neutropenia in these patients after treatment with irinotecan fluorouracil and leucovorin calcium
OUTLINE Patients are stratified according to prior therapy irinotecan fluorouracil and leucovorin calcium vs fluorouracil and leucovorin calcium and prior toxic effects grade 3-4 diarrhea vs grade 4 neutropenia vs grade 1 or lower diarrhea AND grade 2 or lower neutropenia
Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis Genotyping assays are performed to determine UGT1A1 promoter genotyping UGT1A1 coding polymorphisms TS promoter polymorphisms and MTHFR polymorphisms
Determine whether the presence of a 7 allele at the UGT1A1 locus is associated with either grade 3-4 diarrhea or grade 4 neutropenia in patients with stage III colon cancer after treatment with irinotecan fluorouracil and leucovorin calcium
Determine whether polymorphisms in the TS enhancer andor MTHFR gene are associated with grade 3-4 diarrhea in these patients after treatment with fluorouracil and leucovorin calcium
Determine whether polymorphisms in UGT1A1 TS MTHFR CYP3A4 or CYP3A5 are associated with either grade 3-4 diarrhea or grade 4 neutropenia in these patients after treatment with irinotecan fluorouracil and leucovorin calcium
OUTLINE Patients are stratified according to prior therapy irinotecan fluorouracil and leucovorin calcium vs fluorouracil and leucovorin calcium and prior toxic effects grade 3-4 diarrhea vs grade 4 neutropenia vs grade 1 or lower diarrhea AND grade 2 or lower neutropenia
Patients undergo collection of blood specimens for polymerase chain reaction and restriction fragment length polymorphism analysis Genotyping assays are performed to determine UGT1A1 promoter genotyping UGT1A1 coding polymorphisms TS promoter polymorphisms and MTHFR polymorphisms
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 |
|---|---|---|---|
| CALGB-60102 | None | None | None |
| CDR0000257145 | REGISTRY | NCI Physician Data Query | None |
| NCCTG-CALGB-60102 | None | None | None |