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

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NCT00168155

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Study Location
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Adenocarcinoma, Liver Metastases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Colorectal Adenocarcinoma, Liver MetastasesStudy of 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma
NCT00168155
  1. Calgary, Alberta
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Colorectal Adenocarcinoma
  • Liver Metastases
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
 (submitted: September 13, 2005)		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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Oliver Bathe, MDAlberta Health Services
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