Folfox-B Study for Patients With Colorectal Liver Metastases

This study has been terminated.

( Slow accrual, study terminated. )

Study NCT00508872 Information provided by M.D. Anderson Cancer Center

First Received on July 27, 2007. Last Updated on October 8, 2010 History of Changes

Results First Received: October 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Colorectal Liver Metastases
Interventions:	Drug: 5-Fluorouracil Drug: Bevacizumab Drug: Leucovorin Drug: Oxaliplatin

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 11/16/05 through 08/24/07. All participants recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study terminated early due to slow accrual. Two patients recruited, both were taken off study (one at surgery and the second prior to adjuvant care).

Reporting Groups

	Description
FOLFOX-B	FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
FOLFOX-B	FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV

Baseline Measures

	FOLFOX-B
Number of Participants [units: participants]	2
Age [units: years] Mean ( Full Range )	46 ( 36 to 55 )
Gender [units: participants]
Female	0
Male	2
Region of Enrollment [units: participants]
United States	2

Outcome Measures

1. Primary:

Complete Gross Resection Rate [ Time Frame: Over 4 year study period ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Eddie Abdalla, MD/Assistant Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-6940

No publications provided

Responsible Party:	Eddie Abdalla, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00508872 History of Changes
Other Study ID Numbers:	2004-0816
Study First Received:	July 27, 2007
Results First Received:	October 8, 2010
Last Updated:	October 8, 2010
Health Authority:	United States: Institutional Review Board