Back to resultsStudy of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
Xeloda
Calcium folinate (CF)
5-FU
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- More than 18-years old,male or female
- Pathologically approved as unresectable/metastatic colorectal cancer
- KPS > 70% or ECOG 0-2
- HGB > 80 g/L, NEUT ≥ 1.5x109 /L, PLT ≥ 80x109 /L; CR < 1.5 x Upper normality，
- TB < 1.5 X Upper normality，AST or ALT < 2.5 x Upper normality.
- Signed consent
Exclusion Criteria:
- Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer
- Pregnancy or in lactation
- HGB < 80 g/L, NEUT < 1.5x109 /L, PLT < 80x109 /L; CR ≥ 1.5 x Upper normality， TB ≥ 2.5 X Upper normality，AST or ALT ≥2.5 x Upper normality，AKP ≥ 2.5 X Upper normality
Sites / Locations
- Cancer Institute&Hospital Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bevacizumab plus chemotherapy（XELOX or FOLFOX）
Arm Description
Bevacizumab plus XELOX (Bevacizumab 7.5mg/kg d1;Xeloda 2g/m2 d1-14 divided into two times;Oxaliplatin 130mg/m2 d1;repeated in 21 days) Bevacizumab plus FOLFOX (Oxaliplatin 85mg/ m2 ivgtt d1;CF 200mg/ m2 ivgtt d1;Bevacizumab 5mg/kg ivgtt d1 5-FU 400mg /m2 ivgtt d1;5-FU 2400mg/m2 CIV 48h;repeated in 14 days)
Outcomes
Primary Outcome Measures
Overall response rate
During the chemotherapy,all the patients demonstrate CT scan or MR to evaluate tumor response to therapy every two cycles.According to RECIST 1.1,tumor response was recorded.
Secondary Outcome Measures
progression free survival
The start time point was defined as when patients receive the first cycle chemotherapy.The end time point was defined as When tumor response to therapy was evaluated as PD according to RECIST 1.1 or patients die for any reason.
overall survival
From the time patients receive the first cycle chemotherapy to the time they die for any reason.
Number of Participants with Adverse Events
Every cycle we demonstrate routine blood test,routine urine test,routine stool test,blood biochemical test.We recommend patients take blood pressure at least twice a week during the therapy.If needed,patients also need have electrocardiogram test and echocardiography.We will evaluate the toxicity according to CTCAE4.0
Full Information
NCT ID
NCT01679327
First Posted
August 18, 2012
Last Updated
September 5, 2012
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01679327
Brief Title
Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Official Title
Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the relationship of biomarker expression and efficacy of bevacizumab plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3 expression in tumor tissue by IHC and detect those protein expression level in plasma by ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D expression level in plasma by ELISA. The aim of the study is to identify whether those biomarkers could predict Bevacizumab efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab plus chemotherapy（XELOX or FOLFOX）
Arm Type
Experimental
Arm Description
Bevacizumab plus XELOX (Bevacizumab 7.5mg/kg d1;Xeloda 2g/m2 d1-14 divided into two times;Oxaliplatin 130mg/m2 d1;repeated in 21 days) Bevacizumab plus FOLFOX (Oxaliplatin 85mg/ m2 ivgtt d1;CF 200mg/ m2 ivgtt d1;Bevacizumab 5mg/kg ivgtt d1 5-FU 400mg /m2 ivgtt d1;5-FU 2400mg/m2 CIV 48h;repeated in 14 days)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Type
Drug
Intervention Name(s)
Xeloda
Other Intervention Name(s)
Capetabine
Intervention Type
Drug
Intervention Name(s)
Calcium folinate (CF)
Other Intervention Name(s)
Calcium folinate
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Primary Outcome Measure Information:
Title
Overall response rate
Description
During the chemotherapy,all the patients demonstrate CT scan or MR to evaluate tumor response to therapy every two cycles.According to RECIST 1.1,tumor response was recorded.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
progression free survival
Description
The start time point was defined as when patients receive the first cycle chemotherapy.The end time point was defined as When tumor response to therapy was evaluated as PD according to RECIST 1.1 or patients die for any reason.
Time Frame
36 months
Title
overall survival
Description
From the time patients receive the first cycle chemotherapy to the time they die for any reason.
Time Frame
36 months
Title
Number of Participants with Adverse Events
Description
Every cycle we demonstrate routine blood test,routine urine test,routine stool test,blood biochemical test.We recommend patients take blood pressure at least twice a week during the therapy.If needed,patients also need have electrocardiogram test and echocardiography.We will evaluate the toxicity according to CTCAE4.0
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
More than 18-years old,male or female
Pathologically approved as unresectable/metastatic colorectal cancer
KPS > 70% or ECOG 0-2
HGB > 80 g/L, NEUT ≥ 1.5x109 /L, PLT ≥ 80x109 /L; CR < 1.5 x Upper normality，
TB < 1.5 X Upper normality，AST or ALT < 2.5 x Upper normality.
Signed consent
Exclusion Criteria:
Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer
Pregnancy or in lactation
HGB < 80 g/L, NEUT < 1.5x109 /L, PLT < 80x109 /L; CR ≥ 1.5 x Upper normality， TB ≥ 2.5 X Upper normality，AST or ALT ≥2.5 x Upper normality，AKP ≥ 2.5 X Upper normality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yihebali Chi, Doctor
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jinwan WANG
Organizational Affiliation
Chinese Academy of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Institute&Hospital Chinese Academy of Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihebali Chi, MD
Phone
8610-87788145
Email
Yihebalichi@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
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