The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study.
Primary Outcome Measures:
- Determine the free time to disease progression [ Time Frame: within study period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: within study period ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: within study period ] [ Designated as safety issue: No ]
- Time to onset of response [ Time Frame: within treatment period ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: within study period ] [ Designated as safety issue: No ]
- Treatment cycles number [ Time Frame: within treatment period ] [ Designated as safety issue: No ]
- Number of patients who need medicine dose reduction [ Time Frame: within treatment period ] [ Designated as safety issue: No ]
- Safety of the treatments, depending on number and kind of reported adverse events [ Time Frame: within study period ] [ Designated as safety issue: Yes ]
Estimated Enrollment: |
470 |
Study Start Date: |
July 2006 |
Estimated Study Completion Date: |
December 2010 |
Estimated Primary Completion Date: |
July 2010 (Final data collection date for primary outcome measure) |
1: Active Comparator
XELOXA
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Drug: XELOXA
XELOXA Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 One cycle every 3 weeks
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2: Experimental
XELOXA-A
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Drug: XELOXA-A
XELOXA-A Bevacizumab: 7,5 mg/kg, day 1 Oxaliplatino: 130 mg/m2 ; day 1 Capecitabine: 1000 mg/m2 bid, oral, day 1-14 during 6 cycles followed by Bevacizumab until disease progression or premature drop out of study.
One cycle every 3 weeks
|
The purpose of this study is to compare the free time to disease progression of combination therapy with capecitabine, oxaliplatin and bevacizumab until disease progression versus capecitabine, oxaliplatin and bevacizumab for 6 cycles followed by bevacizumab until disease progression or a premature drop out of the study.