Study of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma

Phase 2

Completed

• Conditions: Colorectal Adenocarcinoma; Liver Metastases

• Registration Number: NCT00168155
• Lead Sponsor: Alberta Health services

Brief Summary

When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.

Detailed Description

When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2011-09
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• stage IV colorectal cancer isolated to the liver
• one measurable lesion
• metastases are completely resectable or amenable to ablation
• Karnofsky >70
• Adequate bone marrow function
• adequate hepatic function
• adequate renal function
• informed consent

Exclusion Criteria

• primary tumor not controlled by locoregional treatments
• bilateral portal vein and/or hepatic artery involvement
• previous chemotherapy directed at treatment of metastatic colorectal cancer
• underlying acute or chronic liver disease
• Gilbert's disease
• patients receiving phenytoin or phenobarbital prophylaxis
• presence of any concurrent medical or psychiatric condition that serves as a contraindication to surgery or chemotherapy
• pregnancy
• malignancy other than basal cell or squamous cell carcinoma of the skin within the preceding 5 years
• use of another investigational medication concurrently or within 4 months of enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
disease free survival

Trial Locations

Locations (1)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada