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

PHASE1CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

March 26, 2012

Primary Completion Date

August 28, 2016

Study Completion Date

July 31, 2019

Conditions
Acinar Cell Adenocarcinoma of the PancreasAdenocarcinoma of the GallbladderAdenocarcinoma of Unknown PrimaryAdult Primary Cholangiocellular CarcinomaAdvanced Adult Primary Liver CancerCholangiocarcinoma of the Extrahepatic Bile DuctCholangiocarcinoma of the GallbladderDiffuse Adenocarcinoma of the StomachDuct Cell Adenocarcinoma of the PancreasIntestinal Adenocarcinoma of the StomachLocalized Unresectable Adult Primary Liver CancerMetastatic Carcinoma of Unknown PrimaryMetastatic Extrahepatic Bile Duct CancerMixed Adenocarcinoma of the StomachMucinous Adenocarcinoma of the ColonMucinous Adenocarcinoma of the RectumNewly Diagnosed Carcinoma of Unknown PrimarySignet Ring Adenocarcinoma of the ColonSignet Ring Adenocarcinoma of the RectumStage III Pancreatic CancerStage IIIA Colon CancerStage IIIA Gallbladder CancerStage IIIA Gastric CancerStage IIIA Rectal CancerStage IIIB Colon CancerStage IIIB Gallbladder CancerStage IIIB Gastric CancerStage IIIB Rectal CancerStage IIIC Colon CancerStage IIIC Gastric CancerStage IIIC Rectal CancerStage IV Gastric CancerStage IV Pancreatic CancerStage IVA Colon CancerStage IVA Gallbladder CancerStage IVA Rectal CancerStage IVB Colon CancerStage IVB Gallbladder CancerStage IVB Rectal CancerUnresectable Extrahepatic Bile Duct Cancer
Interventions
DRUG

oxaliplatin

Given IV

DRUG

irinotecan hydrochloride

Given IV

DRUG

leucovorin calcium

Given IV

DRUG

fluorouracil

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

Trial Locations (2)

60201

Evanston CCOP-NorthShore University HealthSystem, Evanston

60637-1470

University of Chicago Comprehensive Cancer Center, Chicago

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Chicago

OTHER

NCT01643499 - Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies | Biotech Hunter | Biotech Hunter