Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Recruitment status was Recruiting
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.
Drug: Calcium folinate (CF)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer|
- Overall response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]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.
- progression free survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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)
Other Name: EloxatinDrug: Xeloda
Other Name: CapetabineDrug: Calcium folinate (CF)
Other Name: Calcium folinateDrug: 5-FU Drug: Bevacizumab
Other Name: Avastin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679327
|Cancer Institute&Hospital Chinese Academy of Medical Sciences||Recruiting|
|Contact: Yihebali Chi, MD 8610-87788145 Yihebalichi@yahoo.com|
|Principal Investigator:||Yihebali Chi, Doctor||Chinese academy of medical science|
|Study Director:||Jinwan WANG||Chinese academy of medical science|