Status:
COMPLETED
Study of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
Lead Sponsor:
Alberta Health services
Collaborating Sponsors:
Pfizer
Conditions:
Colorectal Adenocarcinoma
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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....
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00168155
Start Date
January 1 2002
End Date
May 1 2009
Last Update
January 19 2012
Active Locations (1)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2