Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT01160601
- Lead Sponsor
- Peregrine Pharmaceuticals
- Brief Summary
This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Adults over 18 years of age with a life expectancy of at least 3 months.
- Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
- Adequate hematologic, renal and hepatic function.
- PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.
Key
- Squamous cell, small cell, or mixed histology.
- Known history of bleeding diathesis or coagulopathy.
- Cavitary tumors or tumors abutting large blood vessels.
- Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening.
- Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening.
- Ongoing therapy with oral or parenteral anticoagulants.
- Concurrent estrogens, anti-estrogens or progesterone compounds.
- Grade 2 or higher peripheral neuropathy.
- Radiotherapy within 2 weeks preceding Study Day 1.
- Symptomatic or clinically active brain metastases.
- Major surgery within 4 weeks of Study Day 1.
- Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).
- Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of Screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description paclitaxel/carboplatin plus bavituximab Paclitaxel / Carboplatin Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve \[AUC\] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly. paclitaxel/carboplatin Paclitaxel / Carboplatin Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve \[AUC\] 6) on Day 1 of each 21 day cycle for up to 6 cycles. paclitaxel/carboplatin plus bavituximab bavituximab Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve \[AUC\] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly.
- Primary Outcome Measures
Name Time Method Objective Response Rate Until disease progression
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Medulla Chemotherapy and Immunotherapy Clinic
🇬🇪Tbilisi, Georgia
State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
🇷🇺Ivanovo, Russian Federation
Kodlikeri Memorial Hospital
🇮🇳Aurangabad, Maharashtra, India
BiBi General Hospital & Cancer Centre
🇮🇳Hyderabad, Andhra Pradesh, India
Kyiv City Oncology Hospital, Thoracal Department
🇺🇦Kyiv, Ukraine
Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
🇷🇺Moscow, Russian Federation
Shatabdi Superspecialty Hospital
🇮🇳Nashik, Maharashtra, India
State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University named after academician I.P. Pavlov of Federal Agency of Healthcare and Social Development"
🇷🇺Saint-Petersburg, Russian Federation
Ironwood Cancer and Research Center
🇺🇸Chandler, Arizona, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
The Center for Cancer and Hematologic Disease
🇺🇸Cherry Hill, New Jersey, United States
JSC A.Gvamichava National Oncology Center
🇬🇪Tbilisi, Georgia
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
🇷🇺Chelyabinsk, Russian Federation
Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
Cedar Valley Medical Specialists, PC
🇺🇸Waterloo, Iowa, United States
The Christ Hospital Cancer Center Research
🇺🇸Cincinnati, Ohio, United States
Signal Point Clinical Research Center, LLC
🇺🇸Middletown, Ohio, United States
Mahavir Cancer Sansthan
🇮🇳Patna, Bihar, India
SMS Medical College Hospital
🇮🇳Jaipur, Rajasthan, India
Bangalore Institute of Oncology Specialty Centre
🇮🇳Bangalore, Karnataka, India
State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
🇷🇺Pyatigorsk, Stavropol Territory, Russian Federation
O.P. Jindal Institute of Cancer & Research
🇮🇳Hisar, Haryana, India
State Institution of Healthcare "Tula Regional Oncology Dispensary"
🇷🇺Tula, Russian Federation
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
🇺🇦Dnipropetrovsk, Ukraine
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
🇷🇺Yaroslavl, Yaroslavl Region, Russian Federation
Uzhgorod Central City Clinical Hospital, City Oncology Center
🇺🇦Uzhgorod, Ukraine
Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy department #1
🇺🇦Donetsk, Ukraine
State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
🇺🇦Kharkiv, Ukraine
Baptist Clinical Research
🇺🇸Jonesboro, Arkansas, United States
Community Hospital
🇺🇸Munster, Indiana, United States
Gettysburg Cancer Center
🇺🇸Gettysburg, Pennsylvania, United States
Hematology-Oncology of Knoxville/Mercy Medical Center
🇺🇸Knoxville, Tennessee, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Delta Hematology Oncology Associates, PC
🇺🇸Portsmouth, Virginia, United States
American Institute of Research
🇺🇸Whittier, California, United States
Cancer Care Clinic
🇮🇳Nagpur, Maharashtra, India
Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India