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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1145

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Elderly patients (</= 65 years of age) with newly diagnosed metastatic colorectal cancer starting first-line treatment with Avastin in combination with fluoropyrimidine-based chemotherapy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median progression-free survival	approximately 3.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall response rate (complete response + partial response)	approximately 3.5 years
Clinical benefit rate (complete response + partial response + stable disease)	approximately 3.5 years
Metastasectomy rate	approximately 3.5 years
Mean duration of Avastin treatment	approximately 3.5 years
Safety: Incidence of adverse events	approximately 3.5 years
Median progression-free survival in subgroup receiving Avastin plus fluorouracil monotherapy	approximately 3.5 years
Median progression-free survival according to age group (65-74 years; >/= 75 years)	approximately 3.5 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ML25630