Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer

University of Athens1 site in 1 country150 target enrollmentJanuary 2012

ConditionsNon-small Cell Lung Cancer Unresectable Malignant Neoplasm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-small Cell Lung Cancer
Sponsor: University of Athens
Enrollment: 150
Locations: 1
Primary Endpoint: Number of adverse events during 24 months of follow-up
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This observational trial is designed to assess the safety profile and tolerability of bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC.

Detailed Description

It is an observational study for the safety and tolerability of the combination of bevacizumab with chemotherapy in locally advanced or metastatic and recurrent non-squamous non-small cell lung cancer. We try to evaluate the safety of bevacizumab in real life population with lung cancer. For patients with performance status 0-1 platinum based chemotherapy was recommended and acceptable doses of bevacizumab was either 7.5 or 15 mg/kgr. Safety profile was evaluated with Common Toxicity criteria v 3.0. Especially for bevacizumab we evaluate specific situations as thrombotic or hemorrhagic events, hypertension, albuminuria, and gastrointestinal disorders.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

January 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Athens

Responsible Party

Principal Investigator

Kostas N Syrigos

Professor in Medical Oncology

University of Athens

Eligibility Criteria

Inclusion Criteria

•Written informed consent
•Age ≥18 years
•Able to comply with the protocol
•Histologically or cytologically documented, locally advanced, metastatic (Stage IV) or recurrent non-squamous NSCLC 5.ECOG PS: 0-2
•Life expectancy ≥12 weeks
•Adequate haematological function:
•Absolute neutrophil count (ANC) ≥1.5 x 109/L AND
•Platelet count ≥100 x 109/L AND
•Haemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level)
•Adequate liver function:

Exclusion Criteria

•Mixed, predominant squamous component
•History of haemoptysis, in the 3 months prior to enrolment
•Evidence of tumour invading major blood vessels
•Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases
•Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
•Radical radiotherapy with curative intent within 28 days prior to enrolment. Palliative radiotherapy f is allowed
•Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment
•Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
•Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (\> 325mg/day)
•Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed