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

A Pilot Study of Pharmacokinetically (PK) Dose Adjusted 5-Fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer

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.

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.

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.