Study of 5-FU + Leucovorin + CPT-11 in Patients With Rese... | NCT00168155

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

NCT00168155

Sponsor

Alberta Health services

Status

Completed

Last Update Posted

Jan 19, 2012Estimated

Enrollment

Phase

Phase 2

Conditions

Colorectal Adenocarcinoma
Liver Metastases

Interventions

perioperative chemotherapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2012

Last Update Posted Date

Jan 19, 2012Estimated

Name	Class
Pfizer	INDUSTRY

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
perioperative chemotherapy	Drug

Measure	Description	Time Frame
disease free survival

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oliver Bathe, MD	Alberta Health services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tom Baker Cancer Centre		Calgary	Alberta	T2N 4N2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19457245	Derived	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.