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

Primary Purpose

Colorectal Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
embolization therapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring liver metastases, adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 4, 2002
Last Updated
June 4, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00028626
Brief Title
Portal Vein Embolization in Treating Patients With Liver Metastases From Primary Colorectal Cancer
Official Title
Clinical Efficacy And Biologic Effects Of Preoperative Portal Vein Embolization In Patients With Colorectal Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastatic Cancer
Keywords
liver metastases, adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
embolization therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald DeMatteo, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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