A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)
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.
Non-small Cell Lung Cancer
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer|
- Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ] [ Designated as safety issue: Yes ]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."
- Selected Adverse Events [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ] [ Designated as safety issue: Yes ]
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.
- Adverse Events That Led to Discontinuation of Bevacizumab [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ] [ Designated as safety issue: No ]Any treatment-emergent adverse event leading to study treatment discontinuation
- Progression-free Survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]
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.
|Study Start Date:||September 2005|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
|Experimental: Treated with Bevacizumab||
15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3Drug: Carboplatin
Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cyclesDrug: Paclitaxel
Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles