A Phase II Trial of Isolated Hepatic Perfusion (IHP) and Systemic FOLFOX4 for Subjects With Metastatic Unresectable Colorectal Cancers of the Liver With ≥ 40% Hepatic Tumor Burden
- Determine the response and duration of response in patients with previously untreated
unresectable liver metastases secondary to colorectal cancer treated with isolated
hepatic perfusion with melphalan followed by leucovorin calcium, oxaliplatin, and
- Determine the patterns of recurrence (liver vs systemic) in patients treated with this
- Determine progression-free and overall survival of patients treated with this regimen.
- Correlate health-related quality of life with length of survival of patients treated
with this regimen.
OUTLINE: Patients undergo exploratory laparotomy. Patients with evidence of carcinomatosis
not previously visualized on scans but found on surgical exploration are removed from the
study. All other patients then undergo isolated hepatic perfusion (IHP). Once IHP is
established, melphalan is administered intra-arterially over 3-5 minutes and then circulated
throughout the liver for 1 hour. Approximately 6-12 weeks later, patients receive systemic
chemotherapy comprising oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over
2 hours and fluorouracil IV continuously over 22 hours on days 1-2. Courses with systemic
chemotherapy repeat every 14 days for up to 1 year in the absence of disease progression or
Quality of life is assessed at baseline, after laparotomy, after completion of systemic
chemotherapy, and then every 6 months thereafter.
After completion of study treatment, patients are followed every 3 months for 1 year, every
3-4 months for 2 years, and then every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 years.
Masking: Open Label, Primary Purpose: Treatment
Response and duration of response
H. Richard Alexander, MD, FACS
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|