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

Sponsors and Collaborators:	Alberta Cancer Board Pfizer
Information provided by:	Alberta Cancer Board
ClinicalTrials.gov Identifier:	NCT00168155

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 II

MedlinePlus related topics: Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
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 Alberta Cancer Board:

Primary Outcome Measures:

disease free survival

Estimated Enrollment:	70
Study Start Date:	January 2002

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

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

Alberta Cancer Board

Pfizer

Investigators

Principal Investigator:

Oliver Bathe, MD

Alberta Cancerboard

More Information

Study ID Numbers:	CPTAIV-0020-357
Study First Received:	September 13, 2005
Last Updated:	November 15, 2007
ClinicalTrials.gov Identifier:	NCT00168155
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Cancer Board:

resectable liver metastases
colorectal adenocarcinoma
survival
neoadjuvant chemotherapy

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Irinotecan
Colonic Diseases
Liver neoplasms
Leucovorin
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Carcinoma
Liver Neoplasms
Digestive System Diseases
Fluorouracil
Neoplasm Metastasis
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Neoplasms by Site
Pathologic Processes
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 13, 2009