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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00449163
First Posted: March 19, 2007
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Miami
Results First Submitted: January 23, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Biological: Bevacizumab
Drug: Floxuridine
Drug: Irinotecan
Drug: Leucovorin

  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
  Description
Combination Chemotherapy and Bevacizumab

Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:

  • Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
  • Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
  • Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
  • Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.

Participant Flow:   Overall Study
    Combination Chemotherapy and Bevacizumab
STARTED   25 
COMPLETED   22 
NOT COMPLETED   3 
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
  Description
Combination Chemotherapy and Bevacizumab

Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:

  • Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
  • Irinotecan: 110 mg/m^2 via IV infusion on Days 1, 8, 22, 29;
  • Leucovorin: 500 mg/m^2 via IV infusion on Days 1, 8, 22 and 29;
  • Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.

Baseline Measures
   Combination Chemotherapy and Bevacizumab 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      16  72.7% 
>=65 years      6  27.3% 
Age 
[Units: Years]
Median (Full Range)
 57 
 (38 to 82) 
Sex: Female, Male 
[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:   Rate of Toxicity in Study Participants   [ Time Frame: 2 years ]


  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.


  More Information
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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
e-mail: bardalan@med.miami.edu


Publications of Results:
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) B. Ardalan, M. Feagans, D. Mezentsev, C. Jones, P. R. Subbarayan, G. Walker, M. Sapp, K. Stephenson, J. Ness, D. Franceschi, and A. Livingstone Journal of Clinical Oncology 2009 27:15S, e15114-e15114


Responsible Party: University of Miami
ClinicalTrials.gov 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 )
First Submitted: March 15, 2007
First Posted: March 19, 2007
Results First Submitted: January 23, 2013
Results First Posted: February 28, 2013
Last Update Posted: May 11, 2017