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Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether raising the dose of 5-FU chemotherapy for each person is practical and works well. It is for adults with advanced digestive system cancer who handle the starting dose without serious side effects. Everyone also gets standard doses of oxaliplatin chemotherapy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You have cancer of the colon, rectum, or another digestive organ that has spread or grown nearby and cannot be removed by surgery. This includes stomach, esophagus, appendix, small bowel, and ampulla cancers.
  • You had the needed scans of your chest, belly, and pelvis within 30 days before signing up.
  • You can do all usual activities, or you have some limits on hard physical activity but can walk and do light work.

Who can't join

  • You have ever had oxaliplatin or fluoropyrimidine chemotherapy, or had chemotherapy that treats the whole body in the past 6 months before study treatment starts. Chemotherapy given to help radiation work better is allowed.
  • Your cancer has a known DNA repair problem called mismatch repair deficiency or high microsatellite instability.
  • Testing has shown you lack DPD, a protein that helps your body break down 5-FU.
  • You have another confirmed cancer that the study doctor thinks will need treatment that reaches the whole body during the 6-month study.
  • Your blood tests show neutrophils (infection-fighting cells) below 2,500/mm³, platelets (clotting cells) below 100,000/mm³, or hemoglobin below 9 g/dL; or creatinine or bilirubin above 1.5 times the normal upper limit, or AST/ALT liver tests above 5 times that limit.
  • You cannot give informed consent, meaning you cannot understand and agree to join the study.
  • You are pregnant or breastfeeding.
  • You are in jail or prison, are homeless, or have an active substance use disorder.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NH