A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00118755|
Recruitment Status : Completed
First Posted : July 12, 2005
Results First Posted : March 3, 2011
Last Update Posted : March 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: capecitabine Drug: Oxaliplatin Drug: bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||435 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label Study of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer|
|Study Start Date :||July 2005|
|Primary Completion Date :||April 2009|
850 mg/m^2 po bid on Days 1-14 of each 3-week cycleDrug: Oxaliplatin
130 mg/m^2 IV on Day 1 of each 3-week cycleDrug: bevacizumab
7.5 mg/kg IV on Day 1 of each 3-week cycle
|Active Comparator: 2||
1500 mg/m^2 po bid on Days 1-7 of each 2-week cycleDrug: Oxaliplatin
85 mg/m^2 IV on Day 1 of each 2-week cycleDrug: bevacizumab
5 mg/kg IV on Day 1 of each 2-week cycle
- Progression-free Survival (PFS) [ Time Frame: Time to disease progression or death (through follow-up phase) ]Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).
- Overall Survival [ Time Frame: Time to death (through follow-up phase): Approximate Median of 718 days ]Overall survival was defined as the time from the date of randomization to the date of death, for any cause.
- Best Overall Clinical Response [ Time Frame: Through follow-up phase: Approximate Median of 318 days ]Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered "responders"), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.
- 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 ]Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118755
|Study Director:||Clinical Trials||Hoffmann-La Roche|