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

Phase 2

Not yet recruiting

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Biweekly 5-FLUOROURACIL (5-FU); Drug: Biweekly Modified FOLFOX6; Drug: Biweekly FOLFIRI; Drug: mFOLFOXIRI

• Registration Number: NCT06501989
• Lead Sponsor: Inova Health Care Services

Brief 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.

Detailed Description

5-fluorouracil (5-FU) has been the most widely used agent in the treatment of early stage and advanced colorectal cancer. Traditionally, 5-FU dosing is based on body surface area (BSA). However, BSA-dosing has been associated with a wide range of pharmacokinetic (PK) variability, resulting in marked differences in drug exposure and toxicities in an individual. There is a significant association between the risk of 5-FU-related toxicities and the extent of 5- FU systemic exposure, which can be measured using a well-established pharmacokinetic (PK) assay.

Study Timeline

• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Study Start: 2025-12-15
• Primary Completion: 2026-06-15
• Study Completion: 2026-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Males or females at least 18 years of age.
• Histologically confirmed metastatic colorectal cancer eligible for treatment with 5-FU.
• No prior therapy for metastatic disease. If adjuvant 5-FU or FOLFOX was administered, the last dose must have been at least 6 months prior to the diagnosis of metastatic disease.
• Adequate organ function.
• Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2.
• Life expectancy > 3 months.

Exclusion Criteria

• Untreated brain metastasis. Treated brain metastases are allowed as long as symptoms have resolved off of steroids.
• At least 4 weeks from any prior surgery or 2 weeks from radiation treatments.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both	Biweekly 5-FLUOROURACIL (5-FU)	Plasma specimens will be collected for the measurement of plasma 5-FU level from patients receiving 5-FU/LV alone, with oxaliplatin (mFOLFOX6) or irinotecan (FOLFIRI), or both (mFOLFOXIRI) chemotherapy. 5-FU doses will be modified based on the assay results.
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both	Biweekly Modified FOLFOX6	Plasma specimens will be collected for the measurement of plasma 5-FU level from patients receiving 5-FU/LV alone, with oxaliplatin (mFOLFOX6) or irinotecan (FOLFIRI), or both (mFOLFOXIRI) chemotherapy. 5-FU doses will be modified based on the assay results.
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both	Biweekly FOLFIRI	Plasma specimens will be collected for the measurement of plasma 5-FU level from patients receiving 5-FU/LV alone, with oxaliplatin (mFOLFOX6) or irinotecan (FOLFIRI), or both (mFOLFOXIRI) chemotherapy. 5-FU doses will be modified based on the assay results.
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both	mFOLFOXIRI	Plasma specimens will be collected for the measurement of plasma 5-FU level from patients receiving 5-FU/LV alone, with oxaliplatin (mFOLFOX6) or irinotecan (FOLFIRI), or both (mFOLFOXIRI) chemotherapy. 5-FU doses will be modified based on the assay results.

Primary Outcome Measures

Name	Time	Method
Feasibility Of Pharmacokinetically (PK) Guided Does Adjustment of 5-Fluorouracil (5-FU) In a Community Oncology Setting	From enrollment to the end of treatment at 8 weeks	The Feasibility Of Pharmacokinetically Guided Does Adjustment of 5-Fluorouracil In a Community Oncology Setting is Defined as 80% Success Rate among Patients Who Has Completed Four Sequential PK blood Draws with Subsequent Dose Adjustments During the Treatment with 5-FU based Drug Therapy.

Trial Locations

Locations (1)

Inova Health Care Service; 🇺🇸 Falls Church, Virginia, United States