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Clinical trialNCT02333188CompletedPhase 1Interventional

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

SponsorUniversity of ChicagoEnrollment50Adenocarcinoma of Unknown PrimaryAdult CholangiocarcinomaGallbladder CarcinomaGastric AdenocarcinomaMalignant Gastrointestinal NeoplasmMetastatic Pancreatic Adenocarcinoma+11 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, United States

  • Decatur Memorial Hospital

    Decatur, Illinois, United States

  • Northshore University Health System

    Evanston, Illinois, United States

  • Ingalls Memorial Hospital

    Harvey, Illinois, United States

  • Fort Wayne Medical Oncology/hematology

    Fort Wayne, Indiana, United States

  • Indiana University Medical Center

    Indianapolis, Indiana, United States

  • the University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, United States

  • Virginia Mason

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

FluorouracilIrinotecanLeucovorinPaclitaxel albumin-stabilized nanoparticle formulation
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Dec 2014
Primary completion
31 Dec 2017
Completion
31 Dec 2017
Last update posted
31 May 2023
Registered enrollment
50
Registry id
NCT02333188

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.