A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00349336
First received: July 6, 2006
Last updated: September 12, 2012
Last verified: September 2012
Results First Received: June 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: bevacizumab [Avastin]
Drug: XELOX
Drug: FOLFOX-4

  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
A total of 64 patients in 7 centers were enrolled between 01 August 2006 to 28 May 2008. 37 were included in the pharmacokinetic (PK) analyses.

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
XELOX+Bevacizumab XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
FOLFOX-4+Bevacizumab FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).

Participant Flow:   Overall Study
    XELOX+Bevacizumab     FOLFOX-4+Bevacizumab  
STARTED     32     32  
COMPLETED     19     18  
NOT COMPLETED     13     14  



  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
XELOX+Bevacizumab XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
FOLFOX-4+Bevacizumab FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
Total Total of all reporting groups

Baseline Measures
    XELOX+Bevacizumab     FOLFOX-4+Bevacizumab     Total  
Number of Participants  
[units: participants]
  32     32     64  
Age  
[units: years]
Mean ± Standard Deviation
  55.9  ± 12.56     57.9  ± 10.84     56.9  ± 11.74  
Gender  
[units: participants]
     
Female     13     17     30  
Male     19     15     34  



  Outcome Measures
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1.  Primary:   Weekly Steady-state Exposure of Bevacizumab   [ Time Frame: Up to 48 weeks ]

2.  Secondary:   Time Zero to Last Measurable Plasma Concentration of Bevacizumab   [ Time Frame: Up to 48 weeks ]

3.  Secondary:   Steady-state Exposure of Bevacizumab From Time Zero to Tau   [ Time Frame: Up to 48 weeks ]

4.  Secondary:   Maximum Serum Concentration of Bevacizumab at Steady State   [ Time Frame: Up to 48 weeks ]

5.  Secondary:   Minimum Serum Concentration of Bevacizumab at Steady State   [ Time Frame: Up to 48 weeks ]

6.  Secondary:   Serum Clearance of Bevacizumab   [ Time Frame: Up to 48 weeks ]

7.  Secondary:   Time of Maximum Serum Concentration of Bevacizumab   [ Time Frame: Up to 48 weeks ]

8.  Secondary:   Volume of Distribution of Bevacizumab at Steady State   [ Time Frame: Up to 48 weeks ]

9.  Secondary:   Terminal Half-life of Bevacizumab   [ Time Frame: Up to 48 weeks ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00349336     History of Changes
Other Study ID Numbers: NO20254
Study First Received: July 6, 2006
Results First Received: June 2, 2009
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration