This is a single-arm clinical trial that will evaluate the feasibility of a chemotherapy regimen 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.
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
