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The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel plus bavituximab 1 mg/kg | Experimental |
| |
| Docetaxel plus bavituximab 3 mg/kg | Experimental |
| |
| Docetaxel plus placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel plus bavituximab or placebo | Drug | Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Until disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ironwood Cancer and Research Center | Chandler | Arizona | 85224 | United States | ||
| South Bay Hematology Oncology |
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|
| Campbell |
| California |
| 95008 |
| United States |
| Medical Oncology Care Associates | Orange | California | 92868 | United States |
| American Institute of Research | Whittier | California | 90603 | United States |
| The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc | Boca Raton | Florida | 33486 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| Georgia Cancer Specialists, PC | Atlanta | Georgia | 30341 | United States |
| Northwest Georgia Oncology Centers, PC | Marietta | Georgia | 30060 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Cedar Valley Medical Specialists, PC | Waterloo | Iowa | 50701 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| Frederick Memorial Hospital Regional Cancer Therapy Center | Frederick | Maryland | 21701 | United States |
| Nebraska Hematology Oncology, PC | Lincoln | Nebraska | 68506 | United States |
| Hanover Medical Specialists, PA | Wilmington | North Carolina | 28401 | United States |
| The Christ Hospital Cancer Center Research | Cincinnati | Ohio | 45219 | United States |
| Oncology/ Hematology Care, Inc | Cincinnati | Ohio | 45236 | United States |
| Dayton Clinical Oncology Program | Dayton | Ohio | 45429 | United States |
| Pennsylvania State Hershey Cancer Institute | Hershey | Pennsylvania | 17033 | United States |
| South Carolina Oncology Associates | Columbia | South Carolina | 29210 | United States |
| Sarah Cannon Research Institute, LLC | Nashville | Tennessee | 37203 | United States |
| Coastal Bend Cancer Center | Corpus Christi | Texas | 78404 | United States |
| Mary Crowley Cancer Research Centers | Dallas | Texas | 75201 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Utah Hospitals and Clinics, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| JSC A.Gvamichava National Oncology Center | Tbilisi | Georgia |
| Medulla Chemotherapy and Immunotherapy Clinic | Tbilisi | Georgia |
| BiBi General Hospital & Cancer Centre | Hyderabad | Andhra Pradesh | 500024 | India |
| Nizam's Institute of Medical Sciences | Hyderabad | Andhra Pradesh | 500082 | India |
| Mahavir Cancer Sansthan | Patna | Bihar | 801505 | India |
| O.P. Jindal Institute of Cancer & Research | Hisar | Haryana | 125005 | India |
| Bangalore Institute of Oncology Specialty Centre | Bangalore | Karnataka | 560 027 | India |
| Kidwai Memorial Institute of Oncology | Bangalore | Karnataka | 560029 | India |
| Bharath Hospital and Institute of Oncology | Mysore | Karnataka | 570017 | India |
| Kodlikeri Memorial Hospital | Aurangabad | Maharashtra | 431 005 | India |
| Cancer Care Clinic | Nagpur | Maharashtra | 440012 | India |
| Shatabdi Superspecialty Hospital | Nashik | Maharashtra | 422 005 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411 001 | India |
| SMS Medical College Hospital | Jaipur | Rajasthan | 302 004 | India |
| Chhatrapati Shahuji Maharaj Medical University | Lucknow | Uttar Pradesh | 226003 | India |
| Shanti Mukund Hospital Curie Cancer Center | Delhi | 110 0902 | India |
| All India Institute of Medical Sciences | Delhi | 110029 | India |
| State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology" | Chelyabinsk | 454087 | Russia |
| State Institution of Healthcare " Ivanovo Regional Oncology Dispensary " | Ivanovo | 153013 | Russia |
| Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN" | Moscow | 115478 | Russia |
| 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 | 197022 | Russia |
| State Institution of Healthcare "Pyatigorsk Oncology Dispensary" | Stavropol | 357502 | Russia |
| State Institution of Healthcare "Tula Regional Oncology Dispensary" | Tula | 300053 | Russia |
| State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital" | Yaroslavl | 150054 | Russia |
| City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology; | Dnipropetrovsk | 49102 | Ukraine |
| Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy | Donetsk | 83092 | Ukraine |
| State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy | Kharkiv | 61024 | Ukraine |
| Kyiv City Oncology Hospital, Thoracal Department | Kyiv | 03115 | Ukraine |
| Uzhgorod Central City Clinical Hospital, City Oncology Center | Uzhhorod | 88000 | Ukraine |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C547825 | bavituximab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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