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: July 25, 2014
Last verified: August 2013
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
  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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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
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 ]

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.   Safety Issue:   Yes


  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


No publications provided


Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00449163     History of Changes
Other Study ID Numbers: UMIAMI-20060042, SCCC-2005145, WIRB-20060252
Study First Received: March 15, 2007
Results First Received: January 23, 2013
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration