Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

Description

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

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Study Overview

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Study Details

Study overview

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.

Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen

Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Lebanon

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dartmouth-Hitchcock Medical Center,

Gabriel A Brooks, M.D., PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Study Record Dates

2026-05