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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)
Information provided by (Responsible Party):
University of Miami Identifier:
First received: March 15, 2007
Last updated: December 14, 2016
Last verified: December 2016
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
No text entered.

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

Participant Flow:   Overall Study
    Combination Chemotherapy + Bevacizumab
Physician Decision                3 

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

Baseline Measures
   Single Arm 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      16  72.7% 
>=65 years      6  27.3% 
[Units: Years]
Median (Full Range)
 (38 to 82) 
[Units: Participants]
Count of Participants
Female      11  50.0% 
Male      11  50.0% 
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 ]

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

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

4.  Secondary:   Toxicity   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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.

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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Bach Ardalan MD
Organization: UM/Sylvester Comprehensive Cancer Center
phone: 305-243-4909

Publications of Results:
B. Ardalan, M. Feagans, D. Mezentsev, C. Jones, P. R. Subbarayan, G. Walker, M. Sapp, K. Stephenson, J. Ness, D. Franceschi and A. Livingstone. Phase II study of bevacizumab (B), camptosar (I), high-dose 24-hour continuous intravenous infusion of floxuridine (F) and leucovorin (L) in patients with previously untreated metastatic colon cancer. (B-IFL). Journal of Clinical Oncology, Vol 27, No 15S (May 20 Supplement), 2009: e15114

Responsible Party: University of Miami Identifier: NCT00449163     History of Changes
Other Study ID Numbers: 20060042
SCCC-2005145 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20060252 ( Other Identifier: Western Institutional Review Board )
Study First Received: March 15, 2007
Results First Received: January 23, 2013
Last Updated: December 14, 2016