Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

Trial Title: Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

NCT ID: NCT05780684

Condition: Colorectal Cancer
Esophagus Cancer
Appendix Cancer
Small Bowel Cancer
Ampullary Cancer

Conditions: Official terms:
Gastrointestinal Neoplasms
Esophageal Neoplasms
Appendiceal Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: FOX dose-escalation algorithm
Description: Chemotherapy dose-escalation algorithm based on the FOLFOX and FOLFOXIRI regimens
Arm group label: Study Arm

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Dartmouth-Hitchcock Medical Center

Address:
City: Lebanon
Zip: 03756
Country: United States

Status: Recruiting

Contact:
Last name: Gabriel A Brooks, MD

Phone: 603-650-9474
Email: gabriel.a.brooks@hitchcock.org

Investigator:
Last name: Gabriel A Brooks, MD
Email: Principal Investigator

Start date: July 14, 2023

Completion date: May 2026

Lead sponsor:
Agency: Dartmouth-Hitchcock Medical Center
Agency class: Other

Source: Dartmouth-Hitchcock Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05780684