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

Phase 2

Completed

• Conditions: Colorectal Cancer; Metastatic Cancer

• Registration Number: NCT00089401
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief 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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2004-08-04
• Study First Submitted QC: 2004-08-04
• Study First Posted: 2004-08-05
• Primary Completion: 2006-11
• Study Completion: 2008-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-11
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response
Duration of response

Secondary Outcome Measures

Name	Time	Method
Patterns of tumor recurrence (liver vs systemic)
Progression-free survival
Overall survival
Quality of life

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States