Individualized chemotherapy dosing for gastrointestinal cancer

Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen

This study tests whether giving personalized doses of chemotherapy can help people with advanced gastrointestinal cancers do better with their treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dartmouth-Hitchcock Medical Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Lebanon, New Hampshire)
• Trial ID: NCT05780684 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the feasibility of an adaptive chemotherapy regimen using individualized dose escalation of 5-FU for patients with gastrointestinal cancers who tolerate initial doses well. Participants will also receive standard doses of oxaliplatin alongside 5-FU. The study aims to determine the effectiveness of this tailored approach in improving treatment outcomes for patients with metastatic or locally advanced gastrointestinal cancers.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with metastatic or locally advanced gastrointestinal cancers who have a good tolerance to initial chemotherapy doses.

Not a fit: Patients who have previously received oxaliplatin or fluoropyrimidine chemotherapy, or those with specific genetic deficiencies or second malignancies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized chemotherapy treatments for patients with gastrointestinal cancers.

How similar studies have performed: While individualized dosing strategies are being explored in various contexts, this specific approach using 5-FU and oxaliplatin is relatively novel and has not been extensively tested in prior studies.

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

Where this trial is running

Lebanon, New Hampshire

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (RECRUITING)

Study contacts

• Principal investigator: Gabriel A Brooks, M.D. — Dartmouth-Hitchcock Medical Center
• Study coordinator: Research Nurse

Conditions: Colorectal Cancer, Esophagus Cancer, Appendix Cancer, Small Bowel Cancer, Ampullary Cancer