Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC
Brief 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.
Interventions
DRUGbavituximab plus paclitaxel and carboplatin
Weekly bavituximab dose of 3 mg/kg until disease progression, and up to 6 cycles of carboplatin at a dose of AUC=5 and paclitaxel 175 mg/m2 every 21 days (21-day cycles)
Sponsors
Peregrine Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | one year |
Secondary
| Measure | Time frame |
|---|---|
| Time to tumor progression, duration of response, overall survival and safety | Approximately 1 year |
Countries
India
Outcome results
None listed