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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Oxaliplatin Drug: Xeloda Drug: Calcium folinate (CF) Drug: 5-FU Drug: Bevacizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Study Start Date : March 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
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)
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. overall survival [ Time Frame: 36 months ]
    From the time patients receive the first cycle chemotherapy to the time they die for any reason.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679327


Locations
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China
Cancer Institute&Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Yihebali Chi, MD    8610-87788145    Yihebalichi@yahoo.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Yihebali Chi, Doctor Chinese Academy of Medical Science
Study Director: Jinwan WANG Chinese Academy of Medical Science
More Information
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Responsible Party: yihebali chi, associated professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01679327    
Other Study ID Numbers: WY0524
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium, Dietary
Leucovorin
Bevacizumab
Oxaliplatin
 Calcium
Levoleucovorin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Antidotes
Protective Agents
Vitamin B Complex
Vitamins