Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT05780684
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • FOX dose-escalation algorithm — OTHER
    Chemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens

Study Details

This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.

Key Dates

Start date
Jul 14, 2023
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Study Arm
    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.

Primary Outcome Measure

Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen [ Time Frame: Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Gabriel A Brooks, MD
[email protected]
603-650-9474
Gabriel A Brooks, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lebanon, NH

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Dartmouth-Hitchcock Medical Center· Lebanon, NH

Related Studies