Conditions: Non Small Cell Lung Cancer
Keywords: Non small cell lung cancer NSCLC Pemetrexed Bevacizumab Avastin Carboplatin Stage IIIB/IV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 172
Healthy volunteers: no

Brief summary:
The purpose of this trial is to evaluate three treatment regimens in patients with stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not previously treated.

Detailed description:
This randomized, Phase II trial will evaluate three treatment regimens in patients with previously untreated stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) and a performance status (PS) of 2. Patients will be randomized to either pemetrexed alone, pemetrexed and bevacizumab, or pemetrexed, carboplatin, and bevacizumab in a 1:1:1 fashion. All 3 regimens should be tolerable in poor performance status patients with advanced NSCLC. The 3-drug regimen (pemetrexed/carboplatin/bevacizumab) has been modified by lowering the dose of carboplatin, in order to minimize myelosuppression. This trial will be conducted at multiple study sites.

Arms:
arm 1: * Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
* Bevacizumab 15 mg/kg IV every 21 days arm 2: * Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
* Bevacizumab 15 mg/kg IV every 21 days
* Carboplatin AUC=5 IV every 21 days arm 3: Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days

Interventions: intervention 1: Pemetrexed intervention 2: Bevacizumab intervention 3: Carboplatin
Intervention descriptions: intervention 1: 500 mg/m2 IV given over 10 minutes every 21 days intervention 2: 15 mg/kg IV every 21 days intervention 3: AUC=5 IV every 21 days

Protocol document: