A Phase II Trial Of Isolated Hepatic Perfusion (IHP) With Melphalan For Subjects With Metastatic Unresectable Colorectal Cancers Of The Liver With Disease Refractory To First Line Systemic Chemotherapy
- Determine the response and duration of response in patients with unresectable
colorectal cancer metastatic to the liver and refractory to first-line systemic
chemotherapy treated with isolated hepatic perfusion with melphalan.
- Determine the pattern of recurrence (liver vs systemic) in patients treated with this
- Determine hepatic progression-free and overall survival in patients treated with this
- Determine the time to hepatic and systemic progression in patients treated with this
- Determine quality of life (QOL) in patients treated with this regimen.
- Correlate baseline QOL with length of survival in patients treated with this regimen.
OUTLINE: Patients undergo a limited laparotomy to determine if extrahepatic disease that was
not visualized during preoperative scanning is present. Patients found to have peritoneal
seeding or unresectable extrahepatic metastatic disease not previously visualized on scans
do not receive isolated hepatic perfusion (IHP). Remaining patients undergo IHP with
melphalan and hyperthermia therapy. Liver perfusion continues for 1 hour.
Quality of life is assessed at baseline, 6 weeks, and then every 3-4 months for 3 years.
Patients are followed at 6 weeks, every 3-4 months for 3 years, and then every 6 months
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Steven K. Libutti, MD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|