A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis

Roche

Status and phase

Completed

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: paclitaxel

Drug: carboplatin

Drug: bevacizumab [Avastin]

Drug: erlotinib [Tarceva]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00800202

ML21823

2008-006504-33

Details and patient eligibility

About

This study will assess the efficacy and safety of Avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is until disease prog ression, and the target sample size is 100-500 individuals.

Enrollment

91 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients, >=18 years of age;
stage IV non-squamous non-small cell lung cancer;
asymptomatic, untreated brain metastasis;
ECOG performance status 0-1.

Exclusion criteria

previous treatment for brain metastasis;
history of migraine or epilepsy;
previous treatment with angiogenesis inhibitors;
for cohort 2, previous first line treatment with Avastin or Tarceva;
current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agent for therapeutic purposes.