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

Inova Health Care Services

Status and phase: Not yet enrolling; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Biweekly FOLFIRI; Drug: Biweekly Modified FOLFOX6; Drug: Biweekly 5-FLUOROURACIL (5-FU); Drug: mFOLFOXIRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06501989

INOVA-2024-27

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both

Experimental group

Description:

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.

Treatment:

Drug: mFOLFOXIRI

Drug: Biweekly 5-FLUOROURACIL (5-FU)

Drug: Biweekly Modified FOLFOX6

Drug: Biweekly FOLFIRI