Back to resultsClinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Bevacizumab
Oxaliplatin
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Advanced and/or metastatic colorectal cancer
Eligibility Criteria
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
Sites / Locations
- Hokkaido Region
- Kanto Region
- Kinki Region
- Tokai Region
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Step 1
Step 2
Step 3
Arm Description
Outcomes
Primary Outcome Measures
Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
Secondary Outcome Measures
time to progression
overall survival
time to response
duration of response
concentrations of R340 and its metabolites
concentrations of platinum
concentrations of bevacizumab
concentrations of vascular endothelial growth factor (VEGF)
concentrations of anti-bevacizumab antibody
Full Information
NCT ID
NCT00345761
First Posted
June 27, 2006
Last Updated
August 13, 2010
Sponsor
Chugai Pharmaceutical
Collaborators
Yakult Honsha Co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT00345761
Brief Title
Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
Official Title
Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chugai Pharmaceutical
Collaborators
Yakult Honsha Co., LTD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Advanced and/or metastatic colorectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Step 1
Arm Type
Experimental
Arm Title
Step 2
Arm Type
Experimental
Arm Title
Step 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)
Primary Outcome Measure Information:
Title
Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
event driven
Title
Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
Time Frame
throughout study
Secondary Outcome Measure Information:
Title
time to progression
Time Frame
event driven
Title
overall survival
Time Frame
event driven
Title
time to response
Time Frame
event driven
Title
duration of response
Time Frame
event driven
Title
concentrations of R340 and its metabolites
Time Frame
throughout study
Title
concentrations of platinum
Time Frame
throughout study
Title
concentrations of bevacizumab
Time Frame
throughout study
Title
concentrations of vascular endothelial growth factor (VEGF)
Time Frame
throughout study
Title
concentrations of anti-bevacizumab antibody
Time Frame
throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuji Hayashi
Organizational Affiliation
Clinical Development Department 3, Group 6
Official's Role
Study Chair
Facility Information:
Facility Name
Hokkaido Region
City
Hokkaido
Country
Japan
Facility Name
Kanto Region
City
Kanto
Country
Japan
Facility Name
Kinki Region
City
Kinki
Country
Japan
Facility Name
Tokai Region
City
Tokai
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
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