Isolated Hepatic Perfusion With Melphalan in Treating Patients With Unresectable Colorectal Cancer That Has Metastasized to the Liver
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.
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 Design
Masking: Open Label, Primary Purpose: Treatment
Conditions
Colorectal Cancer
Intervention
isolated perfusion, melphalan, conventional surgery
Location
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda
Maryland
United States
20892-1182
Status
Completed
Source
National Institutes of Health Clinical Center (CC)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00089401
- Information obtained from ClinicalTrials.gov on June 07, 2012
Medical and Biotech [MESH] Definitions
Colorectal Neoplasms
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.
Genes, Mcc
Tumor suppressor genes located in the 5q21 region on the long arm of human chromosome 5. The mutation of these genes is associated with the formation of colorectal cancer (MCC stands for mutated in colorectal cancer).
Genes, Dcc
Tumor suppressor genes located in the 18q21-qter region of human chromosome 18. The absence of these genes is associated with the formation of colorectal cancer (DCC stands for deleted in colorectal cancer). The products of these genes show significant homology to neural cell adhesion molecules and other related cell surface glycoproteins.
Colorectal Neoplasms, Hereditary Nonpolyposis
A group of autosomal-dominant inherited diseases in which COLON CANCER arises in discrete adenomas. Unlike FAMILIAL POLYPOSIS COLI with hundreds of polyps, hereditary nonpolyposis colorectal neoplasms occur much later, in the fourth and fifth decades. HNPCC has been associated with germline mutations in mismatch repair (MMR) genes. It has been subdivided into Lynch syndrome I or site-specific colonic cancer, and LYNCH SYNDROME II which includes extracolonic cancer.
Chemotherapy, Cancer, Regional Perfusion
Neoplasm drug therapy involving an extracorporeal circuit with temporary exclusion of the tumor-bearing area from the general circulation during which high concentrations of the drug are perfused to the isolated part.
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