Genetic Analysis-Guided Dosing of FOLFIRABRAX in Treating Patients With Advanced Gastrointestinal Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT02333188
Phase
PHASE1
Status
Completed

Conditions

  • Adenocarcinoma of Unknown Primary
  • Adult Cholangiocarcinoma
  • Gallbladder Carcinoma
  • Gastric Adenocarcinoma
  • Malignant Gastrointestinal Neoplasm
  • Metastatic Pancreatic Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Stage III Ampulla of Vater Cancer
  • Stage III Pancreatic Cancer
  • Stage IIIA Gallbladder Cancer
  • Stage IIIA Gastric Cancer
  • Stage IIIB Gallbladder Cancer
  • Stage IIIB Gastric Cancer
  • Stage IV Ampulla of Vater Cancer
  • Stage IV Gallbladder Cancer
  • Stage IV Gastric Cancer
  • Stage IV Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • Paclitaxel Albumin-Stabilized Nanoparticle Formulation — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Fluorouracil — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase I/II trial studies the side effects of genetic analysis-guided dosing of paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride (FOLFIRABRAX) in treating patients with gastrointestinal cancer that has spread to other parts of the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.

Key Dates

Start date
Dec 31, 2014
Status verified
May 2023
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

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

Arms

  • Experimental: Treatment (FOLFIRABRAX)
    Patients receive FOLFIRABRAX comprising paclitaxel albumin-stabilized nanoparticle formulation IV over 0.5 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 1.5 hours, and fluorouracil IV over 46 hours on days 1 and 15. Courses repeat every 4 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

DLT rate in course 1 for each of the three genotype groups, graded according to NCI CTCAE v 4.0 [ Time Frame: 4 weeks ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Decatur Memorial HospitalDecaturIllinois62526-
NorthShore University Health SystemEvanstonIllinois60201-
Ingalls Memorial HospitalHarveyIllinois60426-
Fort Wayne Medical Oncology/HematologyFort WayneIndiana46845-
Indiana University Medical CenterIndianapolisIndiana46202-
The University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Virginia MasonSeattleWashington98101-

Find similar trials in Chicago, IL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Chicago Comprehensive Cancer Center· Chicago, ILDecatur Memorial Hospital· Decatur, ILNorthShore University Health System· Evanston, ILIngalls Memorial Hospital· Harvey, ILFort Wayne Medical Oncology/Hematology· Fort Wayne, INIndiana University Medical Center· Indianapolis, IN

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