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NCT06501989 | NOT YET RECRUITING | Metastatic Colorectal Cancer

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

Condition or disease

Metastatic Colorectal Cancer

Intervention/treatment

Biweekly 5-FLUOROURACIL (5-FU)

Biweekly Modified FOLFOX6

Biweekly FOLFIRI

mFOLFOXIRI

Phase

PHASE2

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 Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Pilot Study of Pharmacokinetically (PK) Dose Adjusted 5-Fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer
Actual Study Start Date : 2025-12-15
Estimated Primary Completion Date : 2026-06-15
Estimated Study Completion Date : 2026-08-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer

Location Details

NCT06501989

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Virginia

Inova Health Care Service

Falls Church, Virginia, United States, 22042