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 - SAI

F. Hoffmann-La Roche Ltd0 sites2,000 target enrollmentJune 29, 2006

Overview

No summary available.

Registry

who.int

Start Date

June 29, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients included in the study should have the following criteria:
•1\. Written informed consent (informed consent document to be approved by the institution’s Independent Ethics Committee and patient consent obtained prior to any study\-specific procedure)
•2\. Age \=18 years
•3\. Able to comply with the protocol
•4\. Histologically or cytologically documented inoperable, locally advanced (Stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (Stage IV) or recurrent non\-squamous NSCLC
•5\. ECOG PS 0\-2
•6\. Life expectancy \=12 weeks
•7\. Adequate haematological function
•\- Absolute neutrophil count (ANC) \=1\.5 x 10\[9]/L AND
•\- Platelet count \=100 x 10\[9]/L AND

•Patients with any of the following will be excluded from study entry:
•1\. Mixed, non\-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
•2\. History of haemoptysis, defined as bright red blood of at least half a teaspoon in the 3 months prior to enrolment
•3\. Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g. pulmonary artery or superior vena cava)
•4\. 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
•5\. Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
•6\. Radical radiotherapy with curative intent within 28 days prior to enrolment. Palliative radiotherapy for relief of bone pain not involving thoracic region is allowed prior to enrolment
•7\. Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment
•8\. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
•9\. Current or recent use of aspirin (\>325 mg/day)