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Bevacizumab Plus Capecitabine (Xeloda) in Patients With Untreated Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00203411
First Posted: September 20, 2005
Last Update Posted: February 6, 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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Translational Oncology Research International
Results First Submitted: February 10, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: Capecitabine (Xeloda)
Drug: Bevacizumab

  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
Dates of recruitment period: October 2005 to February 2009 Types of location: Academic medical oncology clinical and community medical oncology clinics

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bevacizumab Plus Capecitabine

Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.

Capecitabine (Xeloda): 1000mg/m2 administered orally twice daily for two weeks followed by one week rest period

Bevacizumab: 7.5 mg/kg IV will be administered every 3 weeks


Participant Flow for 2 periods

Period 1:   Treatment Period
    Bevacizumab Plus Capecitabine
STARTED   45 
COMPLETED   45 
NOT COMPLETED   0 

Period 2:   Follow-up
    Bevacizumab Plus Capecitabine
STARTED   45 
COMPLETED   41 
NOT COMPLETED   4 
Progressive Disease                4 



  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
Bevacizumab Plus Capecitabine Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.

Baseline Measures
   Bevacizumab Plus Capecitabine 
Overall Participants Analyzed 
[Units: Participants]
 45 
Age 
[Units: Years]
Median (Full Range)
 79 
 (54 to 93) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      27  60.0% 
Male      18  40.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      4   8.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3   6.7% 
White      36  80.0% 
More than one race      0   0.0% 
Unknown or Not Reported      2   4.4% 
Region of Enrollment 
[Units: Participants]
 
United States   45 
Eastern Cooperative Oncology Group (ECOG) [1] 
[Units: Subjects]
 
Score of 1   17 
Score of 2   28 
[1]

ECOG Grade Evaluated by Physical Exam 0 Fully active, able to carry on all predisease activities with restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. Ambulatory and capable of all self-care but unable to carry out any work activities. Out of bed > 50%
  3. Capable of only limited self-care, confined to bed or chair > 50% waking hours
  4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Disease Progression   [ Time Frame: 12 months ]

2.  Primary:   Number of Subjects Requiring Dose Modifications   [ Time Frame: 3 months ]

3.  Secondary:   Response Rates   [ Time Frame: every 21 days up to 12 months ]

4.  Secondary:   Quality of Life of Patients   [ Time Frame: Baseline, Cycle 2, and End of Study ]


  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
This was a small study with only 45 participants who received study treatment. With such a small sample size the study does not have the statistical power to make categorical assessments or statements.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Arash Naeim
Organization: Translational Research in Oncology
phone: 310 267-6810
e-mail: anaeim@mednet.ucla.edu



Responsible Party: Translational Oncology Research International
ClinicalTrials.gov Identifier: NCT00203411     History of Changes
Obsolete Identifiers: NCT00217685
Other Study ID Numbers: TORI GI-04
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: February 10, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017