Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer

NCT01912443 | Unknown

• 1 other identifier: ML28629
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

• Incidence, nature and severity of adverse events of special interest

  Gastrointestinal perforation, thromboembolic event, wound healing complication, bleeding, hypertension and proteinuria

  Four years

• Incidence, nature and severity of bevacizumab related serious adverse events

  Four years

• Onset time of adverse event associated with bevacizumab

  Four years

• Laboratory parameters

  Complete blood cell count, electrolytes, hepatic and renal function, coagulation parameters, urinalysis or urine protein

  Four years

Secondary Outcomes (6)

• Overall survival (OS)

  Four years

• Overall response rate (ORR) of treatment line

  Four years

• Progression-free survival (PFS) of treatment line:

  Four years

• One-year disease-free progression rate of treatment line

  One year

• One-year survival rate of treatment line

  One year

Study Arms (1)

Bevacizumab Plus Chemotherapy

Drug: bevacizumab

Interventions

bevacizumab DRUG

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

Also known as: Avastin

Bevacizumab Plus Chemotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed metastatic colorectal cancer are eligible

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Proswell Medical Corporation: collaborator

Study Sites (7)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Liaoning Cancer Hosptial & Institute

Shenyang, Liaoning, 110042, China

RECRUITING

The Second People's Hospital of Sichuan

Chengdu, Sichuan, 610041, China

RECRUITING

First Affiliated Hospital of PLA General Hospital

Beijing, 100048, China

RECRUITING

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Ruihua Xu, Professor

CONTACT

+86-20-87343804; xurh@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of SunYat-sen University Cancer Center,head of medical oncology department

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 31, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2017
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

CN (7)