Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma
- Evaluate the efficacy of hepatic resection followed by portal vein infusion of
floxuridine plus systemic fluorouracil/leucovorin calcium in patients with metastatic
- Study the toxic effects of adjuvant chemotherapy following hepatic resection.
- Evaluate mRNA expression of enzymes that may be important to the cytotoxicity of
fluoropyrimidines in tumor cells, including thymidylate synthase, ribonucleotide
reductase, and folylglutamyl synthetase, by polymerase chain reaction and
OUTLINE: Following resection of the liver and all extrahepatic colorectal cancer, patients
receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists
of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4
weeks for a total of 12 weeks.
If biopsy-proven metastatic disease develops, treatment may be stopped at the investigator's
discretion. Continuation of regional therapy should be considered for extrahepatic failure.
No concurrent radiotherapy is permitted.
Patients are followed every 3 months for 3 years, then every 6 months for survival.
PROJECTED ACCRUAL: It is expected that 50 patients will be entered over approximately 5
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the effect of hepatic resection of colorectal carcinoma followed by systemic chemotherapy on 2 year disease free survival .
2 years after treatment
Lucille A. Leong, MD
Beckman Research Institute
United States: Federal Government
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|