A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00118755
First received: July 1, 2005
Last updated: February 9, 2011
Last verified: February 2011
Results First Received: April 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: capecitabine
Drug: Oxaliplatin
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
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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
XELOX Q3W + Bevacizumab

Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.

Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks.

XELOX Q2W + Bevacizumab

Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.

Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks.


Participant Flow:   Overall Study
    XELOX Q3W + Bevacizumab     XELOX Q2W + Bevacizumab  
STARTED     217     218  
Safety Population     208     211  
COMPLETED     7     3  
NOT COMPLETED     210     215  



  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
XELOX Q3W + Bevacizumab

Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.

Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks.

XELOX Q2W + Bevacizumab

Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.

Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks.

Total Total of all reporting groups

Baseline Measures
    XELOX Q3W + Bevacizumab     XELOX Q2W + Bevacizumab     Total  
Number of Participants  
[units: participants]
  217     218     435  
Age  
[units: years]
Mean ± Standard Deviation
  60.6  ± 11.45     60.8  ± 12.17     60.7  ± 11.81  
Gender  
[units: participants]
     
Female     89     96     185  
Male     128     122     250  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Time to disease progression or death (through follow-up phase) ]

2.  Secondary:   Overall Survival   [ Time Frame: Time to death (through follow-up phase): Approximate Median of 718 days ]

3.  Secondary:   Best Overall Clinical Response   [ Time Frame: Through follow-up phase: Approximate Median of 318 days ]

4.  Secondary:   Duration of Overall Clinical Response (CR or PR)   [ Time Frame: Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days ]


  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: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00118755     History of Changes
Other Study ID Numbers: ML18491
Study First Received: July 1, 2005
Results First Received: April 25, 2010
Last Updated: February 9, 2011
Health Authority: United States: Food and Drug Administration