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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168155
First Posted: September 15, 2005
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
AHS Cancer Control Alberta
  Purpose
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.

Condition Intervention Phase
Colorectal Adenocarcinoma Liver Metastases Drug: perioperative chemotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma

Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • disease free survival

Estimated Enrollment: 70
Study Start Date: January 2002
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168155


Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Alberta Health Services
Pfizer
Investigators
Principal Investigator: Oliver Bathe, MD Alberta Health Services
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00168155     History of Changes
Other Study ID Numbers: CPTAIV-0020-357
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: January 19, 2012
Last Verified: September 2011

Keywords provided by AHS Cancer Control Alberta:
resectable liver metastases
colorectal adenocarcinoma
survival
neoadjuvant chemotherapy

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases