Clinical trial NCT01138163: Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small-cell Lung Cancer
Keywords: NSCLC
second-line
lung cancer
non small cell lung cancer
bavituximab
monoclonal antibody
Lead sponsor: Peregrine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-06-07
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: Until disease progression
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Center
state: Arizona
city: Campbell
country: United States
facility: South Bay Hematology Oncology
state: California
city: Orange
country: United States
facility: Medical Oncology Care Associates
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Boca Raton
country: United States
facility: The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Specialists, PC
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Waterloo
country: United States
facility: Cedar Valley Medical Specialists, PC
state: Iowa
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Frederick
country: United States
facility: Frederick Memorial Hospital Regional Cancer Therapy Center
state: Maryland
city: Lincoln
country: United States
facility: Nebraska Hematology Oncology, PC
state: Nebraska
city: Wilmington
country: United States
facility: Hanover Medical Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center Research
state: Ohio
city: Cincinnati
country: United States
facility: Oncology/ Hematology Care, Inc
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Oncology Program
state: Ohio
city: Hershey
country: United States
facility: Pennsylvania State Hershey Cancer Institute
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute, LLC
state: Tennessee
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Centers
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics, Huntsman Cancer Institute
state: Utah
city: Tbilisi
country: Georgia
facility: JSC A.Gvamichava National Oncology Center
city: Tbilisi
country: Georgia
facility: Medulla Chemotherapy and Immunotherapy Clinic
city: Hyderabad
country: India
facility: BiBi General Hospital & Cancer Centre
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
state: Andra Pradesh
city: Patna
country: India
facility: Mahavir Cancer Sansthan
state: Bihar
city: Hisar
country: India
facility: O.P. Jindal Institute of Cancer & Research
state: Haryana
city: Bangalore
country: India
facility: Bangalore Institute of Oncology Specialty Centre
state: Karnataka
city: Bangalore
country: India
facility: Kidwai Memorial Institute of Oncology
state: Karnataka
city: Mysore
country: India
facility: Bharath Hospital and Institute of Oncology
state: Karnataka
city: Aurangabad
country: India
facility: Kodlikeri Memorial Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Cancer Care Clinic
state: Maharashtra
city: Nashik
country: India
facility: Shatabdi Superspecialty Hospital
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Jaipur
country: India
facility: SMS Medical College Hospital
state: Rajasthan
city: Lucknow
country: India
facility: Chhatrapati Shahuji Maharaj Medical University
state: Uttar Pradesh
city: Delhi
country: India
facility: Shanti Mukund Hospital Curie Cancer Center
city: Delhi
country: India
facility: All India Institute of Medical Sciences
city: Chelyabinsk
country: Russian Federation
facility: State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"
city: Ivanovo
country: Russian Federation
facility: State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "
city: Moscow
country: Russian Federation
facility: Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"
city: Saint Petersburg
country: Russian Federation
facility: 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"
city: Stavropol'
country: Russian Federation
facility: State Institution of Healthcare "Pyatigorsk Oncology Dispensary"
city: Tula
country: Russian Federation
facility: State Institution of Healthcare "Tula Regional Oncology Dispensary"
city: Yaroslavl
country: Russian Federation
facility: State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"
city: Dnipropetrovsk
country: Ukraine
facility: City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;
city: Donetsk
country: Ukraine
facility: Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy
city: Kharkiv
country: Ukraine
facility: State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy
city: Kyiv
country: Ukraine
facility: Kyiv City Oncology Hospital, Thoracal Department
city: Uzhgorod
country: Ukraine
facility: Uzhgorod Central City Clinical Hospital, City Oncology Center
Study officials:
References: