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

NCT01138163 | Completed Phase 2 DMC

• 1 other identifier: PPHM 0902
• Study Type: interventional
• Target: 121
• Locations: 5 countries
• Sites: 53

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.

Conditions

Non-small-cell Lung Cancer

Keywords

NSCLC; second-line; lung cancer; non small cell lung cancer; bavituximab; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Until disease progression

Study Arms (3)

Docetaxel plus bavituximab 1 mg/kg

EXPERIMENTAL

Drug: Docetaxel plus bavituximab or placebo

Docetaxel plus bavituximab 3 mg/kg

EXPERIMENTAL

Drug: Docetaxel plus bavituximab or placebo

Docetaxel plus placebo

PLACEBO COMPARATOR

Drug: Docetaxel plus bavituximab or placebo

Interventions

Docetaxel plus bavituximab or placebo DRUG

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.

Docetaxel plus bavituximab 1 mg/kg; Docetaxel plus bavituximab 3 mg/kg; Docetaxel plus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peregrine Pharmaceuticals: lead

Study Sites (53)

Ironwood Cancer and Research Center

Chandler, Arizona, 85224, United States

Location

South Bay Hematology Oncology

Campbell, California, 95008, United States

Location

Medical Oncology Care Associates

Orange, California, 92868, United States

Location

American Institute of Research

Whittier, California, 90603, United States

Location

The Center for Hematology-Oncology/Boca Raton Community Hospital, Inc

Boca Raton, Florida, 33486, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Georgia Cancer Specialists, PC

Atlanta, Georgia, 30341, United States

Location

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, 30060, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Cedar Valley Medical Specialists, PC

Waterloo, Iowa, 50701, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Frederick Memorial Hospital Regional Cancer Therapy Center

Frederick, Maryland, 21701, United States

Location

Nebraska Hematology Oncology, PC

Lincoln, Nebraska, 68506, United States

Location

Hanover Medical Specialists, PA

Wilmington, North Carolina, 28401, United States

Location

The Christ Hospital Cancer Center Research

Cincinnati, Ohio, 45219, United States

Location

Oncology/ Hematology Care, Inc

Cincinnati, Ohio, 45236, United States

Location

Dayton Clinical Oncology Program

Dayton, Ohio, 45429, United States

Location

Pennsylvania State Hershey Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

South Carolina Oncology Associates

Columbia, South Carolina, 29210, United States

Location

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, 37203, United States

Location

Coastal Bend Cancer Center

Corpus Christi, Texas, 78404, United States

Location

Mary Crowley Cancer Research Centers

Dallas, Texas, 75201, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Utah Hospitals and Clinics, Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

JSC A.Gvamichava National Oncology Center

Tbilisi, Georgia

Location

Medulla Chemotherapy and Immunotherapy Clinic

Tbilisi, Georgia

Location

BiBi General Hospital & Cancer Centre

Hyderabad, Andhra Pradesh, 500024, India

Location

Nizam's Institute of Medical Sciences

Hyderabad, Andhra Pradesh, 500082, India

Location

Mahavir Cancer Sansthan

Patna, Bihar, 801505, India

Location

O.P. Jindal Institute of Cancer & Research

Hisar, Haryana, 125005, India

Location

Bangalore Institute of Oncology Specialty Centre

Bangalore, Karnataka, 560 027, India

Location

Kidwai Memorial Institute of Oncology

Bangalore, Karnataka, 560029, India

Location

Bharath Hospital and Institute of Oncology

Mysore, Karnataka, 570017, India

Location

Kodlikeri Memorial Hospital

Aurangabad, Maharashtra, 431 005, India

Location

Cancer Care Clinic

Nagpur, Maharashtra, 440012, India

Location

Shatabdi Superspecialty Hospital

Nashik, Maharashtra, 422 005, India

Location

Ruby Hall Clinic

Pune, Maharashtra, 411 001, India

Location

SMS Medical College Hospital

Jaipur, Rajasthan, 302 004, India

Location

Chhatrapati Shahuji Maharaj Medical University

Lucknow, Uttar Pradesh, 226003, India

Location

Shanti Mukund Hospital Curie Cancer Center

Delhi, 110 0902, India

Location

All India Institute of Medical Sciences

Delhi, 110029, India

Location

State Medical Preventive Institution "Chelyabinsk Regional Clinical Oncology"

Chelyabinsk, 454087, Russia

Location

State Institution of Healthcare " Ivanovo Regional Oncology Dispensary "

Ivanovo, 153013, Russia

Location

Institution of Russian Academy of Medical Science "Russian Oncology Scientific Centre named after N. N. Blokhina RAMN"

Moscow, 115478, Russia

Location

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, 197022, Russia

Location

State Institution of Healthcare "Pyatigorsk Oncology Dispensary"

Stavropol, 357502, Russia

Location

State Institution of Healthcare "Tula Regional Oncology Dispensary"

Tula, 300053, Russia

Location

State Institution of Healthcare of Yaroslavl Region "Regional Clinical Oncology Hospital"

Yaroslavl, 150054, Russia

Location

City multi-field clinical hospital # 4, Department of chemotherapy; Dnipropetrovsk State Medical Academy, Chair of Oncology and Medical Radiology;

Dnipropetrovsk, 49102, Ukraine

Location

Municipal Clinical Medical and Prophylactic Institution "Donetsk Regional Antineoplastic Center", onco-chemotherapy

Donetsk, 83092, Ukraine

Location

State Institution "Institute of Medical Radiology named after S.P. Grygoryev of AMS of Ukraine", department of chemotherapy

Kharkiv, 61024, Ukraine

Location

Kyiv City Oncology Hospital, Thoracal Department

Kyiv, 03115, Ukraine

Location

Uzhgorod Central City Clinical Hospital, City Oncology Center

Uzhhorod, 88000, Ukraine

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Docetaxel; bavituximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 7, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: May 1, 2013
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

UA (5); RU (7); GE (2); US (24); IN (15)