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Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01679327
Recruitment Status : Unknown
Verified September 2012 by yihebali chi, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 6, 2012
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):
yihebali chi, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE August 18, 2012
First Posted Date  ICMJE September 6, 2012
Last Update Posted Date September 6, 2012
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
Overall response rate [ Time Frame: 36 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • progression free survival [ Time Frame: 36 months ]
    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 [ Time Frame: 36 months ]
    From the time patients receive the first cycle chemotherapy to the time they die for any reason.
  • Number of Participants with Adverse Events [ Time Frame: 36 months ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Oxaliplatin
    Other Name: Eloxatin
  • Drug: Xeloda
    Other Name: Capetabine
  • Drug: Calcium folinate (CF)
    Other Name: Calcium folinate
  • Drug: 5-FU
  • Drug: Bevacizumab
    Other Name: Avastin
Study Arms  ICMJE Experimental: Bevacizumab plus chemotherapy(XELOX or FOLFOX)
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)
Interventions:
  • Drug: Oxaliplatin
  • Drug: Xeloda
  • Drug: Calcium folinate (CF)
  • Drug: 5-FU
  • Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 5, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01679327
Other Study ID Numbers  ICMJE WY0524
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party yihebali chi, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yihebali Chi, Doctor Chinese Academy of Medical Science
Study Director: Jinwan WANG Chinese Academy of Medical Science
PRS Account Chinese Academy of Medical Sciences
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP