Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer

This study has been terminated.

(Study terminated by University of Miami Institutional Review Board)

Sponsor:

Information provided by (Responsible Party):

University of Miami Sylvester Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT00449163

First received: March 15, 2007

Last updated: February 28, 2013

Last verified: February 2013

History of Changes

Results First Received: January 23, 2013

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Colorectal Cancer
Interventions:	Biological: bevacizumab Drug: floxuridine Drug: irinotecan hydrochloride Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: neoadjuvant therapy

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
A total of 25 subjects were enrolled however; data were analyzed for only 22 of the subjects enrolled.

Reporting Groups

	Description
Combination Chemotherapy + Bevacizumab	irinotecan hydrochloride : adjuvant therapy : neoadjuvant therapy : floxuridine : leucovorin calcium : bevacizumab :

Participant Flow: Overall Study

	Combination Chemotherapy + Bevacizumab
STARTED	25
COMPLETED	22
NOT COMPLETED	3
Physician Decision	3

Baseline Characteristics

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Reporting Groups

	Description
Single Arm	irinotecan hydrochloride : adjuvant therapy : neoadjuvant therapy : floxuridine : leucovorin calcium : bevacizumab :

Baseline Measures

	Single Arm
Number of Participants [units: participants]	22
Age [units: participants]
<=18 years	0
Between 18 and 65 years	16
>=65 years	6
Age [units: years] Median ( Full Range )	57 ( 38 to 82 )
Gender [units: participants]
Female	11
Male	11
Region of Enrollment [units: participants]
United States	22

Outcome Measures

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1. Primary:

Overall Survival up to 2 Years [ Time Frame: 2 years ]

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2. Secondary:

Response Rate (Complete Response and Partial Response) [ Time Frame: 2 years ]

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3. Secondary:

Median Progression-free Survival in Months [ Time Frame: 2 years ]

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4. Secondary:

Toxicity [ Time Frame: 2 years ]

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

Serious Adverse Events

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Other Adverse Events

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More Information

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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
A total of 25 subjects were enrolled however; data were analyzed for 22 subjects only. Study was terminated early by the University of Miami Institutional Review Board.

Results Point of Contact:

Name/Title: Bach Ardalan MD
Organization: UM/Sylvester Comprehensive Cancer Center
phone: 305-243-4909
e-mail: bardalan@med.miami.edu

No publications provided

Responsible Party:	University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00449163 History of Changes
Other Study ID Numbers:	EPROST-20060042, SCCC-2005145, WIRB-20060252
Study First Received:	March 15, 2007
Results First Received:	January 23, 2013
Last Updated:	February 28, 2013
Health Authority:	United States: Food and Drug Administration

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