Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peregrine Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Bavituximab; Carboplatin; Paclitaxel

Criteria

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

• Major surgery within 4 weeks of Study Day 1

• Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)

• Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack

• A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. Anti-platelet agents are prohibited during the study.

• Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs, or steroids