This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
5 mg/kg taken intravenously on Day 1 of each 2 week cycle
85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Unnamed facility
PARK Springs, Arizona, United States
Unnamed facility
Sedona, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Anaheim, California, United States
Unnamed facility
Colton, California, United States
Unnamed facility
Progression-free Survival (PFS) in U.S. Patients Only
PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.
Time frame: From first patient enrolled up to approximately 48 months
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Greenbrae, California, United States
Unnamed facility
Loma Linda, California, United States
Unnamed facility
Modesto, California, United States
Unnamed facility
Montebello, California, United States
Unnamed facility
Pomona, California, United States
...and 66 more locations