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Patients receive oxaliplatin IV over 2 hours on, 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.

oxaliplatin

irinotecan hydrochloride

leucovorin calcium

fluorouracil

laboratory biomarker analysis

Hedy Kindler

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

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.

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

To show that the DLT rate is less than 33% with at least 70-80% confidence, which is comparable to the standard 3+3 phase I design with 0 out of 3 or 1 out of 6 patients experiencing a DLT.

National Cancer Institute (NCI)

University of Chicago

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies	NCT01643499	Acinar Cell Ade... Adenocarcinoma ... Adenocarcinoma ... Adult Primary C... Advanced Adult ... Cholangiocarcin... Cholangiocarcin... Diffuse Adenoca... Duct Cell Adeno... Intestinal Aden... Localized Unres... Metastatic Carc... Metastatic Extr... Mixed Adenocarc... Mucinous Adenoc... Mucinous Adenoc... Newly Diagnosed... Signet Ring Ade... Signet Ring Ade... Stage III Pancr... Stage IIIA Colo... Stage IIIA Gall... Stage IIIA Gast... Stage IIIA Rect... Stage IIIB Colo... Stage IIIB Gall... Stage IIIB Gast... Stage IIIB Rect... Stage IIIC Colo... Stage IIIC Gast... Stage IIIC Rect... Stage IV Gastri... Stage IV Pancre... Stage IVA Colon... Stage IVA Gallb... Stage IVA Recta... Stage IVB Colon... Stage IVB Gallb... Stage IVB Recta... Unresectable Ex...	oxaliplatin irinotecan hydr... leucovorin calc... fluorouracil laboratory biom...	18 Years -	University of Chicago
Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies	NCT01643499	Acinar Cell Ade... Adenocarcinoma ... Adenocarcinoma ... Adult Primary C... Advanced Adult ... Cholangiocarcin... Cholangiocarcin... Diffuse Adenoca... Duct Cell Adeno... Intestinal Aden... Localized Unres... Metastatic Carc... Metastatic Extr... Mixed Adenocarc... Mucinous Adenoc... Mucinous Adenoc... Newly Diagnosed... Signet Ring Ade... Signet Ring Ade... Stage III Pancr... Stage IIIA Colo... Stage IIIA Gall... Stage IIIA Gast... Stage IIIA Rect... Stage IIIB Colo... Stage IIIB Gall... Stage IIIB Gast... Stage IIIB Rect... Stage IIIC Colo... Stage IIIC Gast... Stage IIIC Rect... Stage IV Gastri... Stage IV Pancre... Stage IVA Colon... Stage IVA Gallb... Stage IVA Recta... Stage IVB Colon... Stage IVB Gallb... Stage IVB Recta... Unresectable Ex...	oxaliplatin irinotecan hydr... leucovorin calc... fluorouracil laboratory biom...	18 Years -	University of Chicago

Spots Global Cancer Trial Database for metastatic carcinoma of unknown primary