This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth \[po\], day 1 pm-day 15 am every 3 weeks \[q3w\]), oxaliplatin (130 mg/m2 intravenously \[iv\], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)
130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)
2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)
Hokkaido Region
Hokkaido, Hokkaido, Japan
Kanto Region
Kanto, Kanto, Japan
Kinki Region
Kinki, Kinki, Japan
Tokai Region
Tōkai, Tokai, Japan
Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: event driven
Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
Time frame: throughout study
time to progression
Time frame: event driven
overall survival
Time frame: event driven
time to response
Time frame: event driven
duration of response
Time frame: event driven
concentrations of R340 and its metabolites
Time frame: throughout study
concentrations of platinum
Time frame: throughout study
concentrations of bevacizumab
Time frame: throughout study
concentrations of vascular endothelial growth factor (VEGF)
Time frame: throughout study
concentrations of anti-bevacizumab antibody
Time frame: throughout study
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