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

Peregrine Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: bavituximab plus paclitaxel and carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00687817

PPHM 0701

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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