Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Embolization blocks blood flow to part of an organ and/or tumor. Blocking the portal vein on one side of the liver may cause the opposite side of the liver to increase in size and decrease the risk of liver failure following surgery. PURPOSE: Phase II trial to study the effectiveness of portal vein embolization in treating patients who have liver metastases from primary colorectal cancer.


Study summary:

OBJECTIVES: - Determine whether portal vein embolization results in significant hypertrophy of the remaining liver and potentially decreases the risk of liver failure after hepatic resection in patients with liver metastases from primary colorectal cancer. - Determine the biologic effects of this therapy on liver metastases and normal liver parenchyma in these patients. OUTLINE: Patients undergo portal vein embolization with 200-300 micron polyvinyl chloride particles suspended in Iohexol 300. Approximately 3-6 weeks after embolization, patients undergo an exploratory laparotomy followed by hepatic surgical resection. Patients are followed for at least 6 months. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed primary colorectal adenocarcinoma with metastases to the liver being considered for hepatic resection - Requirement for removal of at least 60% of functional liver parenchyma based on CT scan - No extrahepatic disease by laparoscopy PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 2,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.8 mg/dL - AST and ALT no greater than 80 IU/L Renal: - Creatinine no greater than 1.8 mg/dL Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 1 month since prior systemic chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics Other: - At least 2 months since prior investigational treatment


NCT ID:

NCT00028626


Primary Contact:

Study Chair
Ronald DeMatteo, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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