Ignite Creation Date:
2024-05-06 @ 12:44 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01643499
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2012-07-16
Brief Title:
Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Genotype-guided Dosing Study of mFOLFIRINOX in Previously Untreated Patients With Advanced Gastrointestinal Malignancies
Status:
COMPLETED
Status Verified Date:
2020-05
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:
This study is being done to determine the dose of a chemotherapy drug irinotecan irinotecan hydrochloride that can be tolerated as part of a combination of drugs There is a combination of chemotherapy drugs often used to treat gastrointestinal cancer which consists of 5-FU fluorouracil leucovorin leucovorin calcium irinotecan and oxaliplatin and is known as FOLFIRINOX FOLFIRINOX is a current drug therapy combination or regimen used for people with advanced pancreatic cancer although this combination is not Food and Drug Administration FDA approved for this indication FOLFIRINOX was recently shown in a separate clinical trial to increase survival compared to another commonly used drug in pancreatic cancer called gemcitabine FOLFIRINOX is also a reasonable regimen for those with other advanced cancers of the gastrointestinal tract including colon cancer rectal cancer esophagus cancer stomach cancer gall bladder cancer bile duct cancer ampullary cancer and cancers with an unknown primary location The best dose of irinotecan to use in FOLFIRINOX is not known This study will analyze one gene uridine 5-diphospho UDP glucuronosyltransferase 1 family polypeptide A1 UGT1A1 gene of subjects for the presence of an alteration in that gene which may affect how the body handles irinotecan Genes help determine some of the investigators individual characteristics such as eye color height and skin tone Genes may also determine why people get certain diseases and how medicines may affect them The result of the genetic analysis will divide subjects into one of three groups A B or C Group A approximately 45 of subjects will receive the standard dose of irinotecan Group B approximately 45 of subjects will receive a lower dose of irinotecan Group C approximately 10 of subjects will receive an even lower dose of irinotecan
Detailed Description:
PRIMARY OBJECTIVES
I To determine the dose-limiting toxicity DLT rate in cycle 1 in each of two UGT1A1 genotype groups 11 128 using genotype-guided dosing of irinotecan as part of the modified m FOLFIRINOX regimen
SECONDARY OBJECTIVES
I To determine the cumulative dose intensity of irinotecan achieved in each genotype group
II To determine the response rates by Response Evaluation Criteria in Solid Tumors RECIST version 11 for each different disease pancreatic cancer biliary cancers gastric cancer colorectal cancer adenocarcinoma of unknown primary treated in the study
OUTLINE
Patients receive oxaliplatin intravenously IV over 2 hours irinotecan hydrochloride IV over 15 hours leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
I To determine the dose-limiting toxicity DLT rate in cycle 1 in each of two UGT1A1 genotype groups 11 128 using genotype-guided dosing of irinotecan as part of the modified m FOLFIRINOX regimen
SECONDARY OBJECTIVES
I To determine the cumulative dose intensity of irinotecan achieved in each genotype group
II To determine the response rates by Response Evaluation Criteria in Solid Tumors RECIST version 11 for each different disease pancreatic cancer biliary cancers gastric cancer colorectal cancer adenocarcinoma of unknown primary treated in the study
OUTLINE
Patients receive oxaliplatin intravenously IV over 2 hours irinotecan hydrochloride IV over 15 hours leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 15 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
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-2012-00585 | REGISTRY | CTRP Clinical Trial Reporting Program | None |