Clinical trial NCT06501989: Study of 5-fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer
Official title: A Pilot Study of Pharmacokinetically (PK) Dose Adjusted 5-Fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: 5-fluorouracil (5-FU)
pharmacokinetic assay
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each cycle of chemotherapy is 2 weeks long, so you will be receiving treatment on the study for a total of 8 weeks. You will also need additional imaging (CT scans) after you complete the first four cycles of chemotherapy, which brings your total time in the study to about 3 months including treatment and follow-up.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility Of Pharmacokinetically (PK) Guided Does Adjustment of 5-Fluorouracil (5-FU) In a Community Oncology Setting
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Health Care Service
state: Virginia
Study officials:
affiliation: Inova Schar Cancer Institute
name: Jasmine Huynh, MD
role: PRINCIPAL_INVESTIGATOR
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