Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01679327
• Other study ID #: WY0524
• Status: Recruiting
• Phase: Phase 2
• First received: August 18, 2012
• Last updated: September 5, 2012
• Start date: March 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2012
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Oxaliplatin

• Xeloda

• Calcium folinate (CF)

• 5-FU

• Bevacizumab

Locations

Country	Name	City	State
China	Cancer Institute&Hospital Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months	No
Secondary	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.	36 months	No
Secondary	overall survival	From the time patients receive the first cycle chemotherapy to the time they die for any reason.	36 months	No
Secondary	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	36 months	Yes