NCT00976456

Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer

Open-label Study of Bevacizumab (Avastin®) in Combination With Pemetrexed or Pemetrexed and Carboplatin as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: PD Dr. med. Wolfgang Schuette · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, open, randomized (parallel) and comparative phase III. Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression. Arm A: Bevacizumab + pemetrexed Arm B: Bevacizumab + pemetrexed + carboplatin

Detailed description

Primary: * Proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(\> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous NSCLC by progression free survival Secondary: * To assess the efficacy of bevacizumab as measured by overall response rate and overall survival. * To assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin. * To assess quality of life by EORTC questionnaire QLQ-C30 and its lung cancer module LC-13 * To assess activity of daily life (iADL) in relation to ECOG performance status prior to study treatment * To assess patient's outcome and treatment delivery in relation to the Charlson comorbidity score and the Simplified Comorbidity Score

Conditions

• Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab + Pemetrexed	Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks
DRUG	Bevacizumab + Pemetrexed + Carboplatin	Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2009-09-14
• Last updated: 2016-03-10
• Results posted: 2016-03-10

Locations

1 site across 1 country: Germany