Clinical Trials Directory

Trials / Completed

CompletedNCT01643499

Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies

A Genotype-guided Dosing Study of mFOLFIRINOX in Previously Untreated Patients With Advanced Gastrointestinal Malignancies

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
79 (actual)
Sponsor
University of Chicago · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 (\*1\*1, \*1\*28) 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 1.1) 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 1.5 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.

Conditions

Interventions

TypeNameDescription
DRUGoxaliplatinGiven IV
DRUGirinotecan hydrochlorideGiven IV
DRUGleucovorin calciumGiven IV
DRUGfluorouracilGiven IV
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2012-03-26
Primary completion
2016-08-28
Completion
2019-07-01
First posted
2012-07-18
Last updated
2020-05-08

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01643499. Inclusion in this directory is not an endorsement.