Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

NCT ID: NCT05780684

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-14
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Colorectal Cancer; Esophagus Cancer; Appendix Cancer; Small Bowel Cancer; Ampullary Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FOX dose-escalation algorithm

Intervention Type: OTHER

Chemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens

Interventions

FOX dose-escalation algorithm

Chemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Diagnosis of metastatic or locally advanced/inoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers of the stomach, esophagus, appendix, small bowel, and ampulla)
• Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration
• ECOG Performance Status: 0-1

Exclusion Criteria

• Any prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)
• Prior receipt of systemic chemotherapy in the 6 months prior to Day 1 of Cycle 1 of FOX (other than radiation-sensitizing chemotherapy)
• Known mismatch repair deficiency or microsatellite instability-high disease
• Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening
• Any confirmed second malignancy that is likely to require systemic therapy during the course of the six-month study period, in the opinion of the enrolling investigator
• Any of the following baseline laboratory abnormalities:

• Absolute neutrophil count (ANC) < 2,500/mm3
• Platelet count < 100,000/mm3
• Hemoglobin < 9 g/dL
• Creatinine > 1.5 x ULN
• Total bilirubin > 1.5 x ULN
• AST/ALT > 5 x ULN
• Patients who are unable to provide informed consent
• Patients who are pregnant or breastfeeding
• Patients who are incarcerated, homeless, or have active substance use disorders

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gabriel A. Brooks

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabriel A Brooks, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Research Nurse

Role: CONTACT

cancer.research.nurse@hitchcock.org

603-653-3637

Facility Contacts

Gabriel A Brooks, MD

Role: primary

gabriel.a.brooks@hitchcock.org

603-650-9474

Other Identifiers

22BRO873

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY02001873

Identifier Type: -

Identifier Source: org_study_id