This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3
Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles
Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events
To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."
Time frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
Selected Adverse Events
Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions. Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting.
Time frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
Adverse Events That Led to Discontinuation of Bevacizumab
Any treatment-emergent adverse event leading to study treatment discontinuation
Time frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
Progression-free Survival
Progression-free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab. Summary of PFS (median) was estimated from Kaplan-Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley.
Time frame: Length of study
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