Colorectal Cancer
Conditions
Keywords
Advanced and/or metastatic colorectal cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGBevacizumab
7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)
DRUGOxaliplatin
130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)
DRUGCapecitabine
2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)
Sponsors
Yakult Honsha Co., LTD
Chugai Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients 20-74 years of age * Histologically confirmed colorectal cancer * Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease * At least one measurable lesion according to RECIST
Exclusion criteria
* Evidence of clinically detectable ascites at study treatment start * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start. * Evidence of bleeding diathesis or coagulopathy * Serious, non-healing wound, ulcer, or bone fracture * Chronic, daily aspirin (\> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) | event driven |
| Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) | throughout study |
Secondary
| Measure | Time frame |
|---|---|
| time to response | event driven |
| duration of response | event driven |
| concentrations of R340 and its metabolites | throughout study |
| time to progression | event driven |
| concentrations of bevacizumab | throughout study |
| concentrations of vascular endothelial growth factor (VEGF) | throughout study |
| concentrations of anti-bevacizumab antibody | throughout study |
| concentrations of platinum | throughout study |
| overall survival | event driven |
Countries
Japan
Outcome results
None listed