BEVERLY-C: An Observational Study of Avastin (Bevacizumab) in First-Line Treatment in Elderly Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Program for Assessment of Activity and Safety of 1st-line Bevacizumab (Avastin) Therapy in Elderly Patients With Metastatic Colorectal Cancer (BEVERLY-C Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791140
• Other study ID #: ML25630
• Status: Completed
• Phase: N/A
• First received: February 12, 2013
• Last updated: November 1, 2016
• Start date: March 2011
• Est. completion date: May 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Medical Research Council
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy in elderly patients (>/= 65 years of age) with newly diagnosed metastatic colorectal cancer. Patients will be followed until disease progression, death, withdrawal of consent, discontinuation of physician-patient relationship or study closure, whichever comes first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 65 years of age

• Patients with newly diagnosed metastatic colorectal cancer starting first-line treatment with Avastin in combination with fluoropyrimidine-based chemotherapy according to the approved Hungarian Summary of Product Characteristics

• Patients suitable for Avastin treatment as assessed by the treating physician

Exclusion Criteria:

• Any contraindications to Avastin treatment according to the Hungarian Summary of Product Characteristics

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

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median progression-free survival		approximately 3.5 years	No
Secondary	Overall response rate (complete response + partial response)		approximately 3.5 years	No
Secondary	Clinical benefit rate (complete response + partial response + stable disease)		approximately 3.5 years	No
Secondary	Metastasectomy rate		approximately 3.5 years	No
Secondary	Mean duration of Avastin treatment		approximately 3.5 years	No
Secondary	Safety: Incidence of adverse events		approximately 3.5 years	No
Secondary	Median progression-free survival in subgroup receiving Avastin plus fluorouracil monotherapy		approximately 3.5 years	No
Secondary	Median progression-free survival according to age group (65-74 years; >/= 75 years)		approximately 3.5 years	No