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Anti-metabolites

mFOLFIRINOX for Stomach Cancer

Phase 4

Recruiting

Led By Daniel Catenacci

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed locally advanced gastric or esophagogastric adenocarcinoma

Eligible for surgery with curative intent

Must not have

Neuropathy grade 2 or greater

Specific UGT1A1 polymorphism other than *1 or *28

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying how well a combination of modified fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin works in treating patients with gastroesophageal or stomach cancer.

Who is the study for?

This trial is for adults with advanced gastroesophageal or stomach cancer without distant spread. They must be fit for surgery, have certain blood counts and organ functions within set limits, not be pregnant, agree to use birth control, and can't have other cancers or serious illnesses that could interfere with the study.

What is being tested?

The trial tests a personalized dose of Irinotecan in the mFOLFIRINOX regimen (a combination of chemotherapy drugs) based on genetic analysis. The goal is to see if tailoring the dose improves tolerance and effectiveness against locally advanced gastroesophageal or stomach cancer.

What are the potential side effects?

Chemotherapy may cause side effects like nausea, vomiting, diarrhea, fatigue, risk of infection due to low blood cell counts, nerve damage leading to numbness or tingling sensations (neuropathy), liver enzyme changes indicating liver stress or damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of stomach or esophagus cancer confirmed by tissue analysis.

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I am a candidate for surgery aimed at curing my condition.

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My disease is advanced but has not spread far, as shown by a special ultrasound.

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I have had a laparoscopy and diagnostic fluid tests for cancer cells.

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I am fully active and can carry on all pre-disease activities without restriction.

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My liver tests are within required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe nerve damage.

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My genetic test shows I have a UGT1A1 variant that is not *1 or *28.

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I have experienced mild to severe diarrhea.

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I am currently experiencing uncontrolled bleeding.

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I have not had major surgery in the last 4 weeks.

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I have inflammatory bowel disease that is not under control or currently being treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

R0 (analysis will be performed evaluating the R0 rate)

Secondary study objectives

Incidence of toxicity based on NCI-CTCAE v 4.0

OS (estimated using the Kaplan-Meier procedure and compared in the subgroups of patients with and without pCR (grade 1a) using the log-rank test)

Pattern of recurrence

+3 more

Other study objectives

Change in SUVmax for PET/CT studies

Change in SUVmax for the primary esophageal tumor

Circulating tumor cell (CTC) numbers derived from portal and peripheral blood samples

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (mFOLFIRINOX, surgery)Experimental Treatment5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan Hydrochloride

2010

Completed Phase 3

~2050

Oxaliplatin

2011

Completed Phase 4

~2890