NCT00089401

Isolated Hepatic Perfusion With Melphalan in Treating Patients With Unresectable Colorectal Cancer That Has Metastasized to the Liver

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy 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 unresectable colorectal cancer that has metastasized to the liver.

Detailed description

OBJECTIVES: Primary * 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. Secondary * Determine the pattern of recurrence (liver vs systemic) in patients treated with this regimen. * Determine hepatic progression-free and overall survival in patients treated with this regimen. * Determine the time to hepatic and systemic progression in patients treated with this regimen. * 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 thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

Conditions

• Colorectal Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	isolated perfusion
DRUG	melphalan
PROCEDURE	conventional surgery

Timeline

• Start date: 2004-07-01
• Primary completion: 2006-11-01
• Completion: 2008-03-01
• First posted: 2004-08-05
• Last updated: 2012-05-14

Locations

1 site across 1 country: United States