Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01912443
• Other study ID #: ML28629
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2013
• Last updated: April 25, 2014
• Start date: August 2013

Study information

• Verified date: April 2014
• Source: Sun Yat-sen University
• Contact: Ruihua Xu, Professor
• Phone: +86-20-87343804
• Email: xurh[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer

Description:

This is a multi-centre, observational, non-interventional study. Patients with metastatic colorectal cancer eligible for Bevacizumab in combination with chemotherapy treatment will be enrolled in this trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• with histologically confirmed metastatic colorectal cancer

• patients with metastatic colorectal cancer who are eligible for Bevacizumab in combination with chemotherapy treatment

• Written informed consent

• Unlimited line of treatment (first-line or second line is not limited)

Exclusion Criteria:

Patients who are not eligible for Bevacizumab treatment according to locally approved Bevacizumab China package insert will be excluded. The following patients are not eligible for Bevacizumab treatment according to local Bevacizumab China package insert:

• Recent history of serious hemorrhage or hemoptysis of =1/2 teaspoon of red blood

• Proteinuria at baseline: Patients discovered to have = 2 grams of proteinuria/24 hours *

• The measurement of 24-hour proteinuria level is recommended for patients with moderate to high proteinuria risk indicated by clinical judgement. The treatment with bevacizumab should be delayed when proteinuria is =2g/24 hours.

• Major surgical procedure within 28 days prior to treatment initiation, or not fully healed wounds

• Pregnant or lactating women

• Excluding patients known to be allergic to bevacizumab or any of the excipients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• bevacizumab
5 mg/Kg, IV (in the vein) on day 1 and day 14 of each 28 day cycle. Number of Cycles: until progression.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing
China	First Affiliated Hospital of PLA General Hospital	Beijing
China	The Second People's Hospital of Sichuan	Chengdu	Sichuan
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Liaoning Cancer Hosptial & Institute	Shenyang	Liaoning
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Proswell Medical Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, nature and severity of adverse events of special interest	Gastrointestinal perforation, thromboembolic event, wound healing complication, bleeding, hypertension and proteinuria	Four years	Yes
Primary	Incidence, nature and severity of bevacizumab related serious adverse events		Four years	Yes
Primary	Onset time of adverse event associated with bevacizumab		Four years	Yes
Primary	Laboratory parameters	Complete blood cell count, electrolytes, hepatic and renal function, coagulation parameters, urinalysis or urine protein	Four years	Yes
Secondary	Overall survival (OS)	Time from the diagnosis of colorectal cancer to death due to various causes. Patients who do not die at the end of study will be truncated when they do not die at the last collection.	Four years	No
Secondary	Overall response rate (ORR) of treatment line	The best overall response status determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria is defined as the best response status recorded from the enrollment to disease progression (the minimal measurement from baseline assessment is used as the reference for progression). ORR includes complete response (CR) and partial response (PR). The value of change will be summarized according to different treatment lines.	Four years	No
Secondary	Progression-free survival (PFS) of treatment line:	Time from the enrollment to disease progression or death due to various causes, whichever is earlier (Disease progression is according to RECIST 1.1 criteria for tumor assessment). Patients who do not have disease progression or death at the end of study will be truncated at the last tumor assessment. The value of change will be summarized according to different treatment lines.	Four years	No
Secondary	One-year disease-free progression rate of treatment line	The proportion of patients without disease progression within one year since enrollment or with death for other reasons based on analytical population. The value of change will be summarized according to different treatment lines.	One year	No
Secondary	One-year survival rate of treatment line	The proportion of patients without death within one year since enrollment based on analytical population. The value of change will be summarized according to different treatment lines.	One year	No
Secondary	Overall survival (OS) of treatment line	Time from the enrollment to death due to various causes. Patients who do not die at the end of study will be truncated when they do not die at the last collection.	Four years	No