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

Sponsor: Inova Health Care Services

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06501989

Patient View

This study evaluates dose adjustment of 5-FU based on blood concentration to improve metastatic colorectal cancer treatment. Eligibility includes adults with confirmed metastatic colorectal cancer, no prior metastatic therapy, and adequate organ function. Interventions involve biweekly regimens of 5-FU, with options for additional agents like VEGF or EGFR inhibitors, and combinations such as FOLFOX and FOLFIRI.

Patient Parameters

Program Overview

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.

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.

Eligibility Criteria

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.

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