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

Hoffmann-La Roche0 sites3 target enrollmentMarch 2011

ConditionsColorectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 3
Primary Endpoint: Median progression-free survival
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

May 2011

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Median progression-free survival

Time Frame: approximately 3.5 years

Secondary Outcomes

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)