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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT01643499
Phase
PHASE1
Status
Completed

Conditions

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Adenocarcinoma of Unknown Primary
  • Adenocarcinoma of the Gallbladder
  • Adult Primary Cholangiocellular Carcinoma
  • Advanced Adult Primary Liver Cancer
  • Cholangiocarcinoma of the Extrahepatic Bile Duct
  • Cholangiocarcinoma of the Gallbladder
  • Diffuse Adenocarcinoma of the Stomach
  • Duct Cell Adenocarcinoma of the Pancreas
  • Intestinal Adenocarcinoma of the Stomach
  • Localized Unresectable Adult Primary Liver Cancer
  • Metastatic Carcinoma of Unknown Primary
  • Metastatic Extrahepatic Bile Duct Cancer
  • Mixed Adenocarcinoma of the Stomach
  • Mucinous Adenocarcinoma of the Colon
  • Mucinous Adenocarcinoma of the Rectum
  • Newly Diagnosed Carcinoma of Unknown Primary
  • Signet Ring Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Rectum
  • Stage III Pancreatic Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Gallbladder Cancer
  • Stage IIIA Gastric Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Gallbladder Cancer
  • Stage IIIB Gastric Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Gastric Cancer
  • Stage IIIC Rectal Cancer
  • Stage IV Gastric Cancer
  • Stage IV Pancreatic Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Gallbladder Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Gallbladder Cancer
  • Stage IVB Rectal Cancer
  • Unresectable Extrahepatic Bile Duct Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • oxaliplatin — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • fluorouracil — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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

Key Dates

Start date
Mar 26, 2012
Status verified
May 2020
Primary completion
Aug 28, 2016
Completion
Jul 31, 2019

Study Design

Enrollment
79 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (mFOLFIRINOX)
    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.

Primary Outcome Measure

DLT rate in course 1 for each of the two most common genotype groups (*1*1 and *1*28) [ Time Frame: 4 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-1470-
Evanston CCOP-NorthShore University HealthSystemEvanstonIllinois60201-

Find similar trials in Chicago, IL

By research site
University of Chicago Comprehensive Cancer Center· Chicago, ILEvanston CCOP-NorthShore University HealthSystem· Evanston, IL

Related Studies