An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

An Open Label Study of the Effect of First Line Treatment With Bevacizumab in Combination With Capecitabine and Oxaliplatin on Progression-free Survival in Patients With Metastatic Cancer of the Colon and Rectum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399190
• Other study ID #: ML25523
• Status: Completed
• Phase: N/A
• First received: July 20, 2011
• Last updated: June 1, 2016
• Start date: July 2011
• Est. completion date: February 2014

Study information

• Verified date: June 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for the Control of Drugs
• Study type: Observational

Clinical Trial Summary

This prospective observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with Xeloda (capecitabine) and oxaliplatin as first-line treatment in patients with colorectal cancer. Data will be collected from each patient until disease progression occurs (for up to 30 months).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Metastatic colorectal cancer

• Treatment in accordance with current Summary of Product Characteristics and local guidelines

Exclusion Criteria:

• Contraindications according to current Summary of Product Characteristics and local guidelines

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (tumour assessments according to RECIST criteria)		approximately 30 months	No
Secondary	Response rate (tumour assessments according to RECIST criteria)		approximately 30 months	No
Secondary	Safety: Incidence of adverse events		approximately 30 months	No