Status:
COMPLETED
Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
Peregrine Pharmaceuticals
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pr...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00687817
Start Date
June 1 2008
End Date
July 1 2010
Last Update
March 24 2011
Active Locations (9)
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1
Apollo Hospital
Bannerghatta Rd, Banglore, India, 560 076
2
Kidwai Hospital
Munigowda Road, Banglore, India, 560 027
3
M S Ramaiah Hospital
New BEL Rd, Banglore, India, 560 054
4
Bangalore Institute of Oncology Speciality Centre
Sampangi Ram Nagar, Banglore, India, 560 027