Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
- Conditions
- Non-small-cell Lung Cancer
- Interventions
- Registration Number
- NCT01138163
- Lead Sponsor
- Peregrine Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- Adults over age 18 years of age with a life expectancy of at least 3 months.
- Histologically or cytologically confirmed stage IIIB or stage IV non squamous non-small-cell lung cancer (NSCLC) who have progressed after 1 chemotherapy regimen.
- Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Adequate hematologic, renal, and hepatic function.
- PT/INR ≤ 1.5 × ULN; aPTT time ≤ 1.5 × ULN.
- New York Heart Association classification I or II
- Squamous, small cell, or mixed histology.
- Known history of bleeding diathesis or coagulopathy.
- Cavitary tumors or tumors invading or abutting large blood vessels.
- Bleeding: Clinically significant bleeding such as gross hematuria, GI bleeding and hemoptysis within 12 months of Screening.
- Venous thromboembolic events within 6 months of screening.
- Ongoing therapy with oral or parenteral anticoagulants.
- Concurrent estrogens, anti-estrogens or progesterone compounds.
- Radiotherapy within 2 weeks or major surgery within 4 weeks preceding Study Day 1.
- Symptomatic or clinically active brain metastases.
- Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris within 6 months of screening.
- Grade 2 or higher peripheral neuropathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Docetaxel plus bavituximab 1 mg/kg Docetaxel plus bavituximab or placebo - Docetaxel plus bavituximab 3 mg/kg Docetaxel plus bavituximab or placebo - Docetaxel plus placebo Docetaxel plus bavituximab or placebo -
- Primary Outcome Measures
Name Time Method Objective Response Rate Until disease progression
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (53)
The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc
🇺🇸Boca Raton, Florida, United States
Cedar Valley Medical Specialists, PC
🇺🇸Waterloo, Iowa, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Northwest Georgia Oncology Centers, PC
🇺🇸Marietta, Georgia, United States
Hanover Medical Specialists, PA
🇺🇸Wilmington, North Carolina, United States
American Institute of Research
🇺🇸Whittier, California, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
🇺🇸Frederick, Maryland, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Medulla Chemotherapy and Immunotherapy Clinic
🇬🇪Tbilisi, Georgia
Dayton Clinical Oncology Program
🇺🇸Dayton, Ohio, United States
Pennsylvania State Hershey Cancer Institute
🇺🇸Hershey, Pennsylvania, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
JSC A.Gvamichava National Oncology Center
🇬🇪Tbilisi, Georgia
Mary Crowley Cancer Research Centers
🇺🇸Dallas, Texas, United States
Georgia Cancer Specialists, PC
🇺🇸Atlanta, Georgia, United States
Coastal Bend Cancer Center
🇺🇸Corpus Christi, Texas, United States
SMS Medical College Hospital
🇮🇳Jaipur, Rajasthan, India
Medical Oncology Care Associates
🇺🇸Orange, California, United States
South Bay Hematology Oncology
🇺🇸Campbell, California, United States
Nebraska Hematology Oncology, PC
🇺🇸Lincoln, Nebraska, United States
O.P. Jindal Institute of Cancer & Research
🇮🇳Hisar, Haryana, India
Kidwai Memorial Institute of Oncology
🇮🇳Bangalore, Karnataka, India
All India Institute of Medical Sciences
🇮🇳Delhi, India
Ironwood Cancer and Research Center
🇺🇸Chandler, Arizona, United States
Mahavir Cancer Sansthan
🇮🇳Patna, Bihar, India
Bharath Hospital and Institute of Oncology
🇮🇳Mysore, Karnataka, India
Kodlikeri Memorial Hospital
🇮🇳Aurangabad, Maharashtra, India
Nizam's Institute of Medical Sciences
🇮🇳Hyderabad, Andra Pradesh, India
Bangalore Institute of Oncology Specialty Centre
🇮🇳Bangalore, Karnataka, India
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
🇺🇦Dnipropetrovsk, Ukraine
Uzhgorod Central City Clinical Hospital, City Oncology Center
🇺🇦Uzhgorod, Ukraine
Shatabdi Superspecialty Hospital
🇮🇳Nashik, Maharashtra, India
State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
🇷🇺Stavropol', Russian Federation
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
🇷🇺Yaroslavl, Russian Federation
Chhatrapati Shahuji Maharaj Medical University
🇮🇳Lucknow, Uttar Pradesh, India
Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
🇷🇺Moscow, Russian Federation
BiBi General Hospital & Cancer Centre
🇮🇳Hyderabad, Andhra Pradesh, India
Shanti Mukund Hospital Curie Cancer Center
🇮🇳Delhi, India
South Carolina Oncology Associates
🇺🇸Columbia, South Carolina, United States
Cancer Care Clinic
🇮🇳Nagpur, Maharashtra, India
State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
🇷🇺Ivanovo, Russian Federation
Kyiv City Oncology Hospital, Thoracal Department
🇺🇦Kyiv, Ukraine
State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
🇷🇺Chelyabinsk, Russian Federation
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
State Institution of Healthcare "Tula Regional Oncology Dispensary"
🇷🇺Tula, Russian Federation
Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy
🇺🇦Donetsk, Ukraine
State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
🇺🇦Kharkiv, Ukraine
The Christ Hospital Cancer Center Research
🇺🇸Cincinnati, Ohio, United States
Oncology/ Hematology Care, Inc
🇺🇸Cincinnati, Ohio, United States
Sarah Cannon Research Institute, LLC
🇺🇸Nashville, Tennessee, United States
University of Utah Hospitals and Clinics, Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India