Colorectal Cancer Clinical Trial
Official title:
Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | May 2026 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients that receive dose intensified infusional 5-FU in Cycle 6 of the FOX regimen | The proportion of patients who receive dose-intensified infusional 5-FU (dosed at greater than or equal to 2,800 mg/m2) in Cycle 6 of the FOX regimen. | Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days) | |
Secondary | Response rate to chemotherapy | Response rate (stratified by colorectal cancer vs. gastroesophageal cancer) as defined using RECIST 1.1 imaging criteria | Through 6 months from Cycle 1 Day 1 of FOX regimen | |
Secondary | Progression-free survival | Progression-free survival (PFS, stratified by colorectal cancer vs. gastroesophageal cancer, determined by retrospective review of medical records) | Through 12 months from Cycle 1 Day 1 of FOX regimen | |
Secondary | Dose intensity of 5-FU and oxaliplatin | Dose intensity of 5-FU and oxaliplatin over Cycles 1-6. Dose intensity will be calculated separately for each component of the FOLFOX regimen (5-FU infusion and oxaliplatin). | Through day 1 of Cycle 6 of FOX regimen (cycle length is 14 days) | |
Secondary | Mean plasma uracil concentration | Difference in mean plasma uracil concentration between patients who did and did not achieve sustained 5-FU dose escalation to = 2,800 mg/m2 (primary endpoint) | Single treatment visit 0-30 days before Day 1 of Cycle 1 of FOX regimen, (cycle length is 14 days) | |
Secondary | 5-FU drug exposure | 5-FU drug exposure, measured as the area under the drug concentration curve (AUC). AUC will be calculated by multiplying the measured 5-FU concentration at steady state by the 5-FU infusion duration in hours. | Single treatment visit on Day 3 of treament Cycle 5 or Cycle 6 of FOX regimen, (cycle length is 14 days) |
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