Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Non-small-cell Lung Cancer	Drug: Docetaxel plus bavituximab or placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:

Objective Response Rate [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Enrollment:	121
Study Start Date:	June 2010
Study Completion Date:	May 2013
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Docetaxel plus bavituximab 1 mg/kg	Drug: 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.
Experimental: Docetaxel plus bavituximab 3 mg/kg	Drug: 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.
Placebo Comparator: Docetaxel plus placebo	Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138163

Hide Study Locations

Locations

United States, Arizona
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
United States, California
South Bay Hematology Oncology
Campbell, California, United States, 95008
Medical Oncology Care Associates
Orange, California, United States, 92868
American Institute of Research
Whittier, California, United States, 90603
United States, Florida
The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc
Boca Raton, Florida, United States, 33486
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
United States, Georgia
Georgia Cancer Specialists, PC
Atlanta, Georgia, United States, 30341
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Iowa
Cedar Valley Medical Specialists, PC
Waterloo, Iowa, United States, 50701
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States, 21701
United States, Nebraska
Nebraska Hematology Oncology, PC
Lincoln, Nebraska, United States, 68506
United States, North Carolina
Hanover Medical Specialists, PA
Wilmington, North Carolina, United States, 28401
United States, Ohio
The Christ Hospital Cancer Center Research
Cincinnati, Ohio, United States, 45219
Oncology/ Hematology Care, Inc
Cincinnati, Ohio, United States, 45236
Dayton Clinical Oncology Program
Dayton, Ohio, United States, 45429
United States, Pennsylvania
Pennsylvania State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29210
United States, Tennessee
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, United States, 37203
United States, Texas
Coastal Bend Cancer Center
Corpus Christi, Texas, United States, 78404
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75201
United States, Utah
University of Utah Hospitals and Clinics, Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, Georgia
JSC A.Gvamichava National Oncology Center
Tbilisi, Georgia
India
BiBi General Hospital & Cancer Centre
Hyderabad, Andhra Pradesh, India, 500024
Nizam's Institute of Medical Sciences
Hyderabad, Andra Pradesh, India, 500082
Mahavir Cancer Sansthan
Patna, Bihar, India, 801505
O.P. Jindal Institute of Cancer & Research
Hisar, Haryana, India, 125005
Bangalore Institute of Oncology Specialty Centre
Bangalore, Karnataka, India, 560 027
Kidwai Memorial Institute of Oncology
Bangalore, Karnataka, India, 560029
Bharath Hospital and Institute of Oncology
Mysore, Karnataka, India, 570017
Kodlikeri Memorial Hospital
Aurangabad, Maharashtra, India, 431 005
Cancer Care Clinic
Nagpur, Maharashtra, India, 440012
Shatabdi Superspecialty Hospital
Nashik, Maharashtra, India, 422 005
Ruby Hall Clinic
Pune, Maharashtra, India, 411 001
SMS Medical College Hospital
Jaipur, Rajasthan, India, 302 004
Chhatrapati Shahuji Maharaj Medical University
Lucknow, Uttar Pradesh, India, 226003
All India Institute of Medical Sciences
Delhi, India, 110029
Shanti Mukund Hospital Curie Cancer Center
Delhi, India, 110 0902
Russian Federation
State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
Chelyabinsk, Russian Federation, 454087
State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
Ivanovo, Russian Federation, 153013
Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
Moscow, Russian Federation, 115478
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, 197022
State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
Stavropol', Russian Federation, 357502
State Institution of Healthcare "Tula Regional Oncology Dispensary"
Tula, Russian Federation, 300053
State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, Russian Federation, 150054
Ukraine
City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
Dnipropetrovsk, Ukraine, 49102
Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy
Donetsk, Ukraine, 83092
State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
Kharkiv, Ukraine, 61024
Kyiv City Oncology Hospital, Thoracal Department
Kyiv, Ukraine, 03115
Uzhgorod Central City Clinical Hospital, City Oncology Center
Uzhgorod, Ukraine, 88000

Sponsors and Collaborators

Peregrine Pharmaceuticals

More Information

No publications provided

Responsible Party:	Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01138163 History of Changes
Other Study ID Numbers:	PPHM 0902
Study First Received:	June 3, 2010
Last Updated:	May 3, 2013
Health Authority:	United States: Food and Drug Administration India: Drugs Controller General of India

Keywords provided by Peregrine Pharmaceuticals:

NSCLC
second-line
lung cancer

non small cell lung cancer
bavituximab
monoclonal antibody

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases

Respiratory Tract Diseases
Docetaxel
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013