Individualized 5-FU Dosing for Gastrointestinal Cancer (FOXRegimen Trial)

N/A

Recruiting

Led By Gabriel A Brooks, M.D.

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up single treatment visit 0-30 days before day 1 of cycle 1 of fox regimen, (cycle length is 14 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an individualized chemo regimen to see if it is an effective and safe way to treat cancer.

Who is the study for?

This trial is for adults with advanced gastrointestinal cancers, including colorectal and non-colorectal types. Participants must be in good physical condition (ECOG 0-1) and have not received certain chemotherapies recently. They can't join if they are pregnant, breastfeeding, have specific blood or liver issues, drug dependencies, or other serious health conditions.

What is being tested?

The study tests a personalized dose increase of the chemotherapy drug 5-FU for patients who handle an initial dose well. It's combined with standard doses of oxaliplatin to see if this method is feasible and effective without causing severe side effects.

What are the potential side effects?

Potential side effects include those typical of chemotherapy such as nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage from oxaliplatin, and possibly diarrhea due to higher doses of 5-FU.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ single treatment visit 0-30 days before day 1 of cycle 1 of fox regimen, (cycle length is 14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~single treatment visit 0-30 days before day 1 of cycle 1 of fox regimen, (cycle length is 14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and single treatment visit 0-30 days before day 1 of cycle 1 of fox regimen, (cycle length is 14 days) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen

Secondary study objectives

5-FU drug exposure

Dose intensity of 5-FU and oxaliplatin

Mean plasma uracil concentration

+2 more

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: Study ArmExperimental Treatment1 Intervention

All patients in this single-study arm will be exposed to the FOX regimen, an adaptively dose-escalated chemotherapy regimen. The FOX regimen is comprised of oxaliplatin 85 mg/m2 IV on Day 1; leucovorin calcium 350 mg IV on Day 1; and infusional 5-FU IV over 46 hours (Days 1 and 2) - starting at a dose of 2,400 mg/m2 and adaptively adjusted toward a maximum dose of 3,200 mg/m2 over Cycles 2-4 using a clinical algorithm.

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