Overview
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.
Eligibility
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