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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT02366819
Phase
PHASE4
Status
Suspended

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

Eligibility Criteria

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

Interventions

  • Oxaliplatin — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Fluorouracil — DRUG
    Given IV
  • Conventional Surgery — PROCEDURE
    Undergo surgery

Study Details

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.

Key Dates

Start date
Dec 11, 2014
Status verified
Mar 2026
Primary completion
Jun 8, 2026
Completion
Jun 8, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (mFOLFIRINOX, surgery)
    PREOPERATIVE THERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV over 46 hours continuously on day 1. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo conventional surgery. POST-OPERATIVE THERAPY: Beginning 5-10 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV over 46 hours continuously on day 1. Courses repeat every 2 weeks for 4 more courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

R0 (analysis will be performed evaluating the R0 rate) [ Time Frame: During surgery ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Kellogg Cancer Center - Evanston HospitalEvanstonIllinois60201-
NorthShore University HealthSystemEvanstonIllinois60201-

Find similar trials in Chicago, IL

By research site
University of Chicago Comprehensive Cancer Center· Chicago, ILKellogg Cancer Center - Evanston Hospital· Evanston, ILNorthShore University HealthSystem· Evanston, IL

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