Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
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The primary objective of this study is to determine the overall response rate (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small cell lung cancer.
Overall response (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small-cell lung cancer [ Time Frame: one year ]
Secondary Outcome Measures :
Time to tumor progression, duration of response, overall survival and safety [ Time Frame: Approximately 1 year ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
Adults over age 18 years of age with a life expectancy of at least 3 months
Histologically or cytologically confirmed non-small cell lung cancer at stage IIIB (with pleural effusion), stage IV, or recurrence
Measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral CT)
Adequate hematologic (ANC ≥ 1500 cells/µL; Hemoglobin ≥9 g/dL; platelets ≥100,000/µL and ≤500,000/µL ), renal (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min), and hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN)
D-dimer ≤ 2 x ULN
Key Exclusion Criteria:
Small cell or mixed histology
Known history of bleeding diathesis or coagulopathy
Any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or GI bleeding
Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism)
Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
Radiotherapy within 2 weeks preceding Study Day 1
Symptomatic or clinically active CNS disease or metastatic lesions