Colorectal Cancer Clinical Trial
Official title:
A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan for Metastatic Unresectable Cancers of the Liver
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Giving drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan
works in treating patients with primary unresectable liver cancer or liver metastases.
OBJECTIVES:
- Determine response rate, duration of response, and patterns of recurrence in patients
with primary or metastatic, unresectable cancers of the liver after treatment with
isolated hepatic perfusion with melphalan.
- Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the
peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases,
or unresectable pathologically-involved lymph nodes outside area of portahepatis do not
receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan.
Liver perfusion proceeds for 1 hour.
Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until
disease progression.
PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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