Status:
COMPLETED
Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
Lead Sponsor:
Chugai Pharmaceutical
Collaborating Sponsors:
Yakult Honsha Co., LTD
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00345761
Start Date
February 1 2006
End Date
July 1 2010
Last Update
August 16 2010
Active Locations (4)
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1
Hokkaido Region
Hokkaido, Hokkaido, Japan
2
Kanto Region
Kanto, Kanto, Japan
3
Kinki Region
Kinki, Kinki, Japan
4
Tokai Region
Tōkai, Tokai, Japan