MedTrace Logo

Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer

NCT02366819 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-30

No results posted yet for this study

Summary

This pilot clinical trial studies genetic analysis-guided irontecan hydrochloride dosing of modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin (mFOLFIRINOX) in treating patients with gastroesophageal or stomach cancer that has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin, 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. Leucovorin calcium may also help fluorouracil work better. Genetic analysis may help doctors determine what dose of irinotecan hydrochloride patients can tolerate.

Conditions

  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Stage IIB Gastric Cancer
  • Stage IIIA Esophageal Adenocarcinoma
  • Stage IIIA Gastric Cancer
  • Stage IIIB Esophageal Adenocarcinoma
  • Stage IIIB Gastric Cancer
  • Stage IIIC Esophageal Adenocarcinoma
  • Stage IIIC Gastric Cancer

Interventions

DRUG

Oxaliplatin

Given IV

DRUG

Leucovorin Calcium

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

DRUG

Fluorouracil

Given IV

PROCEDURE

Conventional Surgery

Undergo surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Chicago

    lead OTHER

Principal Investigators

  • Daniel Catenacci · University of Chicago Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-11
Primary Completion
2026-06-08
Completion
2026-06-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02366819 on ClinicalTrials.gov