A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression-free Survival (PFS) [ Time Frame: Time to disease progression or death (through follow-up phase) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2005|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
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