Study of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
NCT00168155
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Study of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma | |||
Official Title ICMJE | Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma | |||
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: perioperative chemotherapy | |||
Study Arms ICMJE | Not Provided | |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 70 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2009 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00168155 | |||
Other Study ID Numbers ICMJE | CPTAIV-0020-357 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Alberta Health Services | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | AHS Cancer Control Alberta | |||
Verification Date | September 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |