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
Conditions
Colorectal CancerEsophagus CancerAppendix CancerSmall Bowel CancerAmpullary Cancer
Locations
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States