Portal Vein Embolization in Treating Patients With Liver Metastases From Primary Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Clinical Efficacy And Biologic Effects Of Preoperative Portal Vein Embolization In Patients With Colorectal Liver Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00028626
• Other study ID #: 01-113
• Secondary ID: CDR0000069112NCI
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2002
• Last updated: June 4, 2013
• Start date: August 2001
• Est. completion date: January 2004

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• embolization therapy

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,