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

Liver Metastases Clinical Trial

Official title:

Phase 2 Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients With Resectable Liver Metastases From Colorectal Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168155
• Other study ID #: CPTAIV-0020-357
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: January 18, 2012
• Start date: January 2002
• Est. completion date: May 2009

Study information

• Verified date: September 2011
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinoma
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• perioperative chemotherapy

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Alberta Health Services	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival