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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
435
850 mg/m\^2 po bid on Days 1-14 of each 3-week cycle
130 mg/m\^2 IV on Day 1 of each 3-week cycle
7.5 mg/kg IV on Day 1 of each 3-week cycle
1500 mg/m\^2 po bid on Days 1-7 of each 2-week cycle
85 mg/m\^2 IV on Day 1 of each 2-week cycle
5 mg/kg IV on Day 1 of each 2-week cycle
Progression-free Survival (PFS)
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).
Time frame: Time to disease progression or death (through follow-up phase)
Overall Survival
Overall survival was defined as the time from the date of randomization to the date of death, for any cause.
Time frame: Time to death (through follow-up phase): Approximate Median of 718 days
Best Overall Clinical Response
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.
Time frame: Through follow-up phase: Approximate Median of 318 days
Duration of Overall Clinical Response (CR or PR)
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.
Time frame: Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days
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