Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
NCT00345761 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2010-08-16
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.
Conditions
Interventions
- DRUG
-
7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)
- DRUG
-
130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)
- DRUG
-
2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)
Sponsors & Collaborators
-
Yakult Honsha Co., LTD
collaborator INDUSTRY -
Chugai Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Yuji Hayashi · Clinical Development Department 3, Group 6
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-02-28
- Primary Completion
- 2008-10-31
- Completion
- 2010-07-31
Countries
- Japan
Study Locations
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