Back to Trials
NCT05780684NARecruiting

Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

Dartmouth-Hitchcock Medical Center

Start Date

7/14/2023

Completion Date

12/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

FOX dose-escalation algorithm

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Colorectal CancerEsophagus CancerAppendix CancerSmall Bowel CancerAmpullary Cancer

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States