Individualized chemotherapy dosing for gastrointestinal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: cancer.research.nurse@hitchcock.org
• Phone: 603-653-3637

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.