Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer Malignant pleural effusions
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: no

Brief summary:
The primary objective of this study will be to determine the progression free survival of patients with stage IIIb/IV non-small cell lung cancer (NSCLC) treated with dual agent monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with two different regimens of paclitaxel and carboplatin chemotherapy.

Detailed description:

Arms:
arm 1: Cycles 1-6:

* Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
* Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
* Paclitaxel 200 mg/m² on day 1 of every 3 week cycle
* Carboplatin area under curve (AUC=6 min\*mg/mL) on day 1 of every 3 week cycle

Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met arm 2: Cycles 1-6:

* Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
* Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle

Cycles 1-3:

* Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
* Carboplatin AUC=6 min\*mg/mL on day 1 of each 3 week cycle for the first 3 cycles

Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Interventions: intervention 1: Cetuximab intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously intervention 3: Administered intravenously intervention 4: Administered intravenously

Protocol document: