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Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer

NCT06501989 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-02-11

No results posted yet for this study

Summary

The purpose of this research is to see if adjusting the dose of 5-fluorouracil based on its concentration in your blood will improve the treatment of your metastatic colon cancer.

Conditions

Interventions

DRUG

Biweekly 5-FLUOROURACIL (5-FU)

5-FU 2400 mg/m². Infusion for 46 hours. Leucovorin 200 mg/m². Either a vascular endothelial growth factor (VEGF) inhibitor or epidermal growth factor (EGFR) inhibitor or may be added to the regimen at the discretion of the treating physician. Repeat every 2 weeks.

DRUG

Biweekly Modified FOLFOX6

Oxaliplatin 85 mg/m². 5-FU 400 mg/m² on day 1 as bolus (OPTIONAL). 5-FU 2400 mg/m² Infusion for 46 hours. Leucovorin 200 mg/m2. Repeat every 2 weeks

DRUG

Biweekly FOLFIRI

Irinotecan 180 mg/m2. 5-FU 400 mg/m2 on day 1 as bolus (OPTIONAL). 5-FU 2400 mg/m2 Infusion for 46 hours. Leucovorin 200 mg/m2. Repeat every 2 weeks.

DRUG

mFOLFOXIRI

Irinotecan 165 mg/m2. Oxaliplatin 85 mg/m2. 5-FU 2400 mg/m2 Infusion for 46 hours. Repeat every 2 weeks.

Sponsors & Collaborators

  • Inova Health Care Services

    lead OTHER

Principal Investigators

  • Jasmine Huynh, MD · Inova Schar Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-19
Primary Completion
2025-09-19
Completion
2025-09-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06501989 on ClinicalTrials.gov