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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00168155
First received: September 13, 2005
Last updated: January 18, 2012
Last verified: September 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168155

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

No publications provided by AHS Cancer Control Alberta

Additional 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
Study First Received: September 13, 2005
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

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
Colorectal 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
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014