Back to resultsStudy of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
Primary Purpose
Colorectal Adenocarcinoma, Liver Metastases
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
perioperative chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Adenocarcinoma focused on measuring resectable liver metastases, colorectal adenocarcinoma, survival, neoadjuvant chemotherapy
Eligibility Criteria
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
Sites / Locations
- Tom Baker Cancer Centre
Outcomes
Primary Outcome Measures
disease free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00168155
First Posted
September 13, 2005
Last Updated
January 18, 2012
Sponsor
Alberta Health services
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00168155
Brief Title
Study of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
Official Title
Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alberta Health services
Collaborators
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenocarcinoma, Liver Metastases
Keywords
resectable liver metastases, colorectal adenocarcinoma, survival, neoadjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
perioperative chemotherapy
Primary Outcome Measure Information:
Title
disease free survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Bathe, MD
Organizational Affiliation
Alberta Health services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
19457245
Citation
Bathe OF, Ernst S, Sutherland FR, Dixon E, Butts C, Bigam D, Holland D, Porter GA, Koppel J, Dowden S. A phase II experience with neoadjuvant irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) for colorectal liver metastases. BMC Cancer. 2009 May 20;9:156. doi: 10.1186/1471-2407-9-156.
Results Reference
derived
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Study of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
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