Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer

April 25, 2014 updated by: Ruihua Xu, Sun Yat-sen University
To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen University Cancer Center
    • Henan
      • Zhengzhou, Henan, China, 450008
      • Zhengzhou, Henan, China, 450052
    • Liaoning
      • Shenyang, Liaoning, China, 110042
    • Sichuan
      • Chengdu, Sichuan, China, 610041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically confirmed metastatic colorectal cancer are eligible

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bevacizumab Plus Chemotherapy
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.
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence, nature and severity of adverse events of special interest
Time Frame: Four years
Gastrointestinal perforation, thromboembolic event, wound healing complication, bleeding, hypertension and proteinuria
Four years
Incidence, nature and severity of bevacizumab related serious adverse events
Time Frame: Four years
Four years
Onset time of adverse event associated with bevacizumab
Time Frame: Four years
Four years
Laboratory parameters
Time Frame: Four years
Complete blood cell count, electrolytes, hepatic and renal function, coagulation parameters, urinalysis or urine protein
Four years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Four years
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
Overall response rate (ORR) of treatment line
Time Frame: Four years
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
Progression-free survival (PFS) of treatment line:
Time Frame: Four years
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
One-year disease-free progression rate of treatment line
Time Frame: One year
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
One-year survival rate of treatment line
Time Frame: One year
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
Overall survival (OS) of treatment line
Time Frame: Four years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Proswell Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 25, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28629

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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