Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- National Cancer Center
- Asan Medical Center
- Samsung Medical Center
- Seoul National University Hospital
- Yonsei University Hospital
- Bundang Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Bevacizumab
Arm Description
Bevacizumab, capecitabine and oxaliplatin for metastatic colorectal cancer, 1st line treatment
Outcomes
Primary Outcome Measures
time to progression
Secondary Outcome Measures
overall survival, safety, response
Full Information
NCT ID
NCT00378066
First Posted
September 18, 2006
Last Updated
January 21, 2013
Sponsor
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00378066
Brief Title
Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer
Official Title
A Phase II Study of Combination Chemotherapy With Bevacizumab, Capecitabine and Oxaliplatin in Patients With Previously Untreated Metastatic or Recurrent Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab
Arm Type
Active Comparator
Arm Description
Bevacizumab, capecitabine and oxaliplatin for metastatic colorectal cancer, 1st line treatment
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Capecitabine, Oxaliplatin
Intervention Description
Bevacizumab, Capecitabine, Oxaliplatin
Primary Outcome Measure Information:
Title
time to progression
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival, safety, response
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Won Kim, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Bundang Seoul National University Hospital
City
Sungnam
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer
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