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Expanded Cohort for Metastatic Colorectal Cancer (MCRC) Using Bevacizumab + Everolimus (BEV/EV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597506
First Posted: January 18, 2008
Last Update Posted: December 27, 2012
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.
Collaborators:
Novartis Pharmaceuticals
Genentech, Inc.
Information provided by (Responsible Party):
Herbert Hurwitz, Duke University Medical Center
Results First Submitted: July 10, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Adenocarcinoma
Interventions: Drug: Bevacizumab
Drug: Everolimus

  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
The recruitment process started in October 2007 and was complete in April 2009. All subjects except one were enrolled at the Morris Cancer Clinic at Duke University Medical Center. One subject was enrolled at the Community Memorial Healthcenter in South Hill, Virgina which is a Duke Oncology Network clinical research site.

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
Drug: Bevacizumab and Everolimus Open-label, non-randomized expanded cohort trial of refractory metastatic colorectal cancer subjects treated on 28 day cycles with the following treatment regimen: 10 mg/kg intravenous bevacizumab on days 1 and 15 each cycle and 10 mg everolimus(RAD001) daily by mouth.

Participant Flow:   Overall Study
    Drug: Bevacizumab and Everolimus
STARTED   50 
COMPLETED   49 
NOT COMPLETED   1 
Subject is being followed for survival                1 



  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.
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Reporting Groups
  Description
Bevacizumab and Everolimus Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus

Baseline Measures
   Bevacizumab and Everolimus 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   40 
>=65 years   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 56  (10.8) 
Gender 
[Units: Participants]
 
Female   20 
Male   30 
Region of Enrollment 
[Units: Participants]
 
United States   50 


  Outcome Measures
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1.  Primary:   Overall Response   [ Time Frame: Measured 1 month after the last treated subject came off treatment ]

2.  Primary:   Progression Free Survival (PFS)   [ Time Frame: interval between start of treatment and 8-week ]


  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
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  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: Herbert Hurwitz, MD
Organization: Duke University Medical Center
phone: 919-668-1861
e-mail: herbert.hurwitz@duke.edu



Responsible Party: Herbert Hurwitz, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00597506     History of Changes
Other Study ID Numbers: Pro00001574
First Submitted: December 26, 2007
First Posted: January 18, 2008
Results First Submitted: July 10, 2012
Results First Posted: August 16, 2012
Last Update Posted: December 27, 2012