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Anti-metabolites

sFOLFOXIRI for Gastroesophageal Cancer

Phase 2

Recruiting

Led By Patrick Boland, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 - 2

Histologically and/or cytologically confirmed metastatic or unresectable adenocarcinoma of esophageal, gastroesophageal junction or gastric origin

Must not have

Clinically significant autoimmune disease which is active or has required systemic immunosuppression within the last two years

No active use of systemic corticosteroids at the time of enrollment, at a dose equivalent of 10 mg/day or prednisone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment regimen to see if it is effective in terms of objective response rate, progression free survival, and overall survival. They will also be looking at the safety and toxicity profile of the new treatment.

Who is the study for?

Adults with advanced gastroesophageal cancer that's HER2 negative and hasn't spread to the brain can join. They should be relatively fit (ECOG PS 0-2), have measurable disease, no recent major surgery or other cancers, and not be on high-dose steroids. No prior treatment for metastatic cancer is allowed except some mFOLFOX6 cycles.

What is being tested?

The trial tests sFOLFOXIRI, a combination of chemotherapy drugs given in four-week cycles, to see how well it works against advanced gastroesophageal cancer by measuring tumor response rate, progression-free survival time, and overall survival time.

What are the potential side effects?

Potential side effects include reactions to the chemo like nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. There may also be liver issues due to elevated enzymes and possible nerve damage causing numbness or tingling.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer originates from the esophagus, gastroesophageal junction, or stomach and cannot be surgically removed.

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My tumor is not HER2 positive according to tests.

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I am 18 years old or older.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

Exclusion Criteria

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

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I have an autoimmune disease that hasn't needed strong medication in the last 2 years.

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I am not currently taking steroids equivalent to 10 mg/day of prednisone.

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I do not have any severe ongoing illnesses like heart failure or uncontrolled infections.

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I am allergic to one or more of the drugs used in this study.

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I have brain metastases that have not been treated.

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I have had interstitial lung disease or pneumonitis.

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I have had an organ or bone marrow transplant.

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I experience significant numbness or pain in my hands or feet.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three years

This trial's timeline: 3 weeks for screening, Varies for treatment, and three 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

Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors ( RECIST) criteria version 1.1

Overall Survival (OS)

Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: 4week alternating FOLFOX and a combination chemotherapy regime FOLFIRI (sFOLFOXIRI),Experimental Treatment1 Intervention

A cycle will constitute 28 days of treatment, which will consist of one chemotherapy combination, either FOLFOX or FOLFIRI as below: 1. Odd Cycles (e.g. 1, 3, 5, etc...) - mFOLFOX6 initiated on days 1 \& 15: (Oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours) 2. Even Cycles (e.g. 2,4,6, etc...) - FOLFIRI initiated on days 1 \& 15: (Irinotecan 180 mg/m2 IV, leucovorin 400 mg/m2, 5FU 400 mg/m2 bolus, then 5FU 2400 mg/m2 over 46 hours) 3. Nivolumab (optional, in-line with labelled approval) - 240 mg every 2 weeks

0 / 14Eligibility criteria met