121
Participants
Start Date
June 30, 2010
Primary Completion Date
October 31, 2012
Study Completion Date
May 31, 2013
Docetaxel plus bavituximab or placebo
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.
Pennsylvania State Hershey Cancer Institute, Hershey
Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick
Hanover Medical Specialists, PA, Wilmington
South Carolina Oncology Associates, Columbia
Northwest Georgia Oncology Centers, PC, Marietta
Georgia Cancer Specialists, PC, Atlanta
The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc, Boca Raton
Florida Cancer Specialists, Fort Myers
Sarah Cannon Research Institute, LLC, Nashville
Jewish Hospital, Louisville
The Christ Hospital Cancer Center Research, Cincinnati
Oncology/ Hematology Care, Inc, Cincinnati
Dayton Clinical Oncology Program, Dayton
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;, Dnipropetrovsk
Cedar Valley Medical Specialists, PC, Waterloo
Rush University Medical Center, Chicago
"State Institution Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine, department of chemotherapy", Kharkiv
Nebraska Hematology Oncology, PC, Lincoln
Mary Crowley Cancer Research Centers, Dallas
University of Texas Southwestern Medical Center, Dallas
Coastal Bend Cancer Center, Corpus Christi
"Municipal Clinical Medical and Prophylactic Institution Donetsk Regional Antineoplastic Center, onco-chemotherapy", Donetsk
University of Utah Hospitals and Clinics, Huntsman Cancer Institute, Salt Lake City
Ironwood Cancer and Research Center, Chandler
Uzhgorod Central City Clinical Hospital, City Oncology Center, Uzhhorod
American Institute of Research, Whittier
Medical Oncology Care Associates, Orange
South Bay Hematology Oncology, Campbell
All India Institute of Medical Sciences, Delhi
"Institution of Russian Academy of Medical Science Russian Oncology Scientific Centre named after N. N. Blokhina RAMN", Moscow
O.P. Jindal Institute of Cancer & Research, Hisar
"State Institution of Healthcare of Yaroslavl Region Regional Clinical Oncology Hospital", Yaroslavl
"State Institution of Healthcare Ivanovo Regional Oncology Dispensary ", Ivanovo
"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
Chhatrapati Shahuji Maharaj Medical University, Lucknow
"State Institution of Healthcare Tula Regional Oncology Dispensary", Tula
"State Institution of Healthcare Pyatigorsk Oncology Dispensary", Stavropol
Cancer Care Clinic, Nagpur
"State Medical Preventive Institution Chelyabinsk Regional Clinical Oncology", Chelyabinsk
BiBi General Hospital & Cancer Centre, Hyderabad
Nizam's Institute of Medical Sciences, Hyderabad
Kidwai Memorial Institute of Oncology, Bangalore
Bharath Hospital and Institute of Oncology, Mysore
Mahavir Cancer Sansthan, Patna
JSC A.Gvamichava National Oncology Center, Tbilisi
Medulla Chemotherapy and Immunotherapy Clinic, Tbilisi
Bangalore Institute of Oncology Specialty Centre, Bangalore
Kodlikeri Memorial Hospital, Aurangabad
Shatabdi Superspecialty Hospital, Nashik
Ruby Hall Clinic, Pune
SMS Medical College Hospital, Jaipur
Shanti Mukund Hospital Curie Cancer Center, Delhi
Kyiv City Oncology Hospital, Thoracal Department, Kyiv
Lead Sponsor
Peregrine Pharmaceuticals
INDUSTRY