Study of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedJanuary 19, 2012
September 1, 2011
7.3 years
September 13, 2005
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease free survival
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alberta Health serviceslead
- Pfizercollaborator
Study Sites (1)
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Related Publications (1)
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.
PMID: 19457245DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Bathe, MD
Alberta Health services
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
January 1, 2002
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
January 19, 2012
Record last verified: 2011-09