Study on 5-Fluorouracil (5-FU) for Patients with Metastatic Colorectal Cancer

Sponsor: Inova Health Care Services

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06501989

Provider View

This clinical trial is exploring whether adjusting the dose of the chemotherapy drug 5-fluorouracil (5-FU) based on its levels in the blood can improve treatment outcomes for patients with metastatic colorectal cancer.

Patient Parameters

Program Overview

The aim of this study is to determine if changing the dose of 5-fluorouracil (5-FU) according to its concentration in the blood can enhance the treatment of metastatic colorectal cancer. 5-FU is a common drug used to treat both early and advanced stages of colorectal cancer. Traditionally, the dose is calculated based on body size, but this method can lead to varying drug levels and side effects in different people. By measuring the drug's presence in the blood, researchers hope to better manage its effects and reduce side effects.

Description

5-fluorouracil (5-FU) is a widely used chemotherapy drug for treating colorectal cancer, both in early and advanced stages. Typically, the dose of 5-FU is determined by a person's body size, but this can lead to different levels of the drug in the body, causing varying side effects. This study aims to see if adjusting the dose based on blood levels of 5-FU can improve treatment outcomes and reduce side effects. Researchers will use a special test to measure how much 5-FU is in the blood, which will help them adjust the dose more accurately for each patient.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 and older.
  • Diagnosed with metastatic colorectal cancer and eligible for 5-FU treatment.
  • No previous treatment for metastatic cancer. If previously treated with 5-FU or FOLFOX, the last dose must have been at least 6 months before the cancer spread.
  • Must have good organ function.
  • Must be in relatively good health, with an ECOG performance status of 2 or less.
  • Expected to live more than 3 months.

Exclusion Criteria

  • Have untreated cancer that has spread to the brain. Treated brain metastases are allowed if symptoms have improved without steroids.
  • Must be at least 4 weeks from any major surgery or 2 weeks from radiation therapy.
  • Cannot have a known deficiency in the enzyme dihydropyrimidine dehydrogenase (DPD).

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