Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer

This study has been completed.

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

Sarah Cannon Research Institute

ClinicalTrials.gov Identifier:

NCT00193219

First received: September 12, 2005

Last updated: March 6, 2013

Last verified: March 2013

History of Changes

Results First Received: December 7, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Colon Cancer
Interventions:	Drug: Bevacizumab Drug: Cetuximab Drug: 5-fluorouracil Drug: Leucovorin Drug: Oxaliplatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Bevacizumab/Cetuximab/FOLFOX	Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV

Participant Flow: Overall Study

	Bevacizumab/Cetuximab/FOLFOX
STARTED	36
COMPLETED	6
NOT COMPLETED	30

Baseline Characteristics

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Reporting Groups

	Description
Bevacizumab/Cetuximab/FOLFOX	Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV

Baseline Measures

	Bevacizumab/Cetuximab/FOLFOX
Number of Participants [units: participants]	36
Age [units: years] Median ( Full Range )	55 ( 29 to 78 )
Gender [units: participants]
Female	16
Male	20
Region of Enrollment [units: participants]
United States	36

Outcome Measures

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1. Primary:

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]

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2. Secondary:

Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease [ Time Frame: 18 months ]

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3. Secondary:

Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 36 months ]

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4. Secondary:

Safety of FOLFOX6 Combined With Bevacizumab and Cetuximab [ Time Frame: 18 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.

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
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Results Point of Contact:

Name/Title: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: ASKSARAH@scresearch.net

Publications:

Spigel DR, Greco FA, Waterhouse D, Shipley D, Lane CM, Vazquez ER, Clark BL, Infante JR, Bendell JC, Burris HA 3rd, Hainsworth JD. Phase II trial of FOLFOX6, bevacizumab, and cetuximab in the first-line treatment of metastatic colorectal cancer. Clin Adv Hematol Oncol. 2010 Jul;8(7):480-5, 498.

Responsible Party:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193219 History of Changes
Other Study ID Numbers:	SCRI GI 64
Study First Received:	September 12, 2005
Results First Received:	December 7, 2012
Last Updated:	March 6, 2013
Health Authority:	United States: Institutional Review Board

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