NCT00378066CompletedPhase 2
A Phase II Study of Combination Chemotherapy With Bevacizumab, Capecitabine and Oxaliplatin in Patients With Previously Untreated Metastatic or Recurrent Colorectal Cancer
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 49
- Locations
- 6
- Primary Endpoint
- time to progression
Study Overview
Brief Summary
The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically documented colorectal adenocarcinoma
- •ECOG performance status of 2 or lower
- •Adequate bone marrow function
- •Adequate kidney function
- •Adequate liver function
- •Informed consent
Exclusion Criteria
- •Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start
- •Known allergy to study drugs
Arms & Interventions
Bevacizumab
Active Comparator
Bevacizumab, capecitabine and oxaliplatin for metastatic colorectal cancer, 1st line treatment
Intervention: Bevacizumab (Drug)
Outcomes
Primary Outcomes
time to progression
Time Frame: 6 months
Secondary Outcomes
- overall survival, safety, response(1 year)
Investigators
Tae Won Kim
Professor
Asan Medical Center
Study Sites (6)
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