Phase II Study of Isolated Hepatic Perfusion With Melphalan Followed By Postoperative Hepatic Arterial Chemotherapy in Patients With Unresectable Colorectal Cancer Metastatic to the Liver
OBJECTIVES: I. Determine the response rate and response duration in patients with
unresectable colorectal cancer metastatic to the liver treated with isolated hepatic
perfusion with melphalan followed by postoperative hepatic arterial chemotherapy.
II. Determine the patterns of recurrence in this patient population with this treatment
III. Evaluate the disease-free survival and overall survival in these patients.
IV. Evaluate health related quality of life and determine whether baseline correlates with
the length of survival.
PROTOCOL OUTLINE: Patients undergo surgery and hyperthermic isolated hepatic perfusion with
melphalan given intra-arterially over 60 minutes.
At six weeks post-hepatic perfusion, patients receive floxuridine and leucovorin calcium
intra-arterially as a continuous infusion over 14 days. Treatment repeats every 28 days in
the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to study and then at each followup visit. Patients are
followed every 3-4 months for 3 years and then every 6 months thereafter or until disease
A total of 50 patients will be accrued for this study.
Primary Purpose: Treatment
H. Richard Alexander, Jr.
National Cancer Institute (NCI)
United States: Federal Government
|Surgery Branch||Bethesda, Maryland 20892|