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

Non-small-cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138163
• Other study ID #: PPHM 0902
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2010
• Last updated: April 18, 2017
• Start date: June 2010
• Est. completion date: May 2013

Study information

• Verified date: April 2017
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Countries where clinical trial is conducted

United States,  Georgia,  India,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		Until disease progression