Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer | NCT00707304 | Trialant

Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer | NCT00707304 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Histologically or cytologically confirmed stage IIIB or IV NSCLC

Failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic NSCLC

At least one target lesion that is unirradiated and measurable by RECIST

Adequate hematologic, renal and hepatic function

ECOG 0, 1, or 2

Able to understand and sign an Informed Consent

Exclusion Criteria:

Presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization

Any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications

History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years

Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure

Serious active infection

Psychiatric illness/ social situations that would limit study compliance

Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol

Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)

Known HIV positive or on active anti-retroviral therapy

Known Hepatitis B surface antigen positive or hepatitis C positive

Receipt of any investigational medication within 4 weeks prior to randomization

Pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment

Sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment

Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian

Desert Oasis Cancer Center

Casa Grande, Arizona 85122, United States

Arizona Oncology Associates

Tucson, Arizona 85710, United States

University of Colorado Hospital

Aurora, Colorado 80045, United States

Pasco Pinellas Cancer Center

New Port Richey, Florida 34652, United States

Emory University

Atlanta, Georgia 30322, United States

Rush University Medical Center

Chicago, Illinois 60612, United States

Cancer Care Specialists of Central Illinois

Decatur, Illinois 62526, United States

Cancer Care & Hematology Specialists of Chicagoland

Niles, Illinois 60714, United States

Central Indiana Cancer Centers

Greenfield, Indiana 46140, United States

Kansas City Cancer Center, LLC

Overland Park, Kansas 66210, United States

NCI, CCR, The Waren Grant Magnuson Clinical Center

Bethesda, Maryland 20892, United States

Newland Medical Associates

Southfield, Michigan 48075, United States

Minnesota Oncology and Hematology, PA

Minneapolis, Minnesota 55405, United States

Washington University School of Medicine

St Louis, Missouri 63128, United States

Southeast Nebraska Cancer Center

Lincoln, Nebraska 68510, United States

NH Oncology-Hematology, PA

Hooksett, New Hampshire 03106, United States

University of Rochester Medical Center

Rochester, New York 14642, United States

Montefiore Medical Center

The Bronx, New York 10467, United States

Alamance Regional Medical Center

Burlington, North Carolina 27216, United States

Duke University Medical Center

Durham, North Carolina 27710, United States

Rex Cancer Center

Raleigh, North Carolina 27609, United States

Legacy Pharma Research

Bismarck, North Dakota 58501, United States

Signal Point Clinical Research Center

Middletown, Ohio 45042, United States

Kaiser Group Health

Portland, Oregon 97227, United States

Texas Oncology

Dallas, Texas 75230, United States

Texas Oncology

Fort Worth, Texas 76104, United States

Tyler Cancer Center

Tyler, Texas 75702, United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Salem, Virginia 24153, United States

Cancer Care Northwest

Spokane, Washington 99202, United States

Campbelltown Hospital

Campbelltown, New South Wales 2560, Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales 2444, Australia

Townsville Hospital

Townsville, Queensland 4814, Australia

The Queen Elisabeth Hospital

Woodville South, South Australia 5011, Australia

Epworth Healthcare

Richmond, Victoria 3121, Australia

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, Pleven 5800, Bulgaria

DDODIU-Plovdiv, EOOD

Aleksandur Stamboliyski, Plovdiv 4004, Bulgaria

DDODIU-Plovdiv, EOOD

Plovdiv, Plovdiv 4004, Bulgaria

DDODIU - Sofia District EOOD

Sofia, 1233, Bulgaria

UMHAT 'Tsaritsa Yoanna - ISUL', EAD

Sofia, 1527, Bulgaria

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2, Canada

Mount Sinai Hospital

Toronto, Ontario M5G 1X5, Canada

Hôtel-Dieu de Lévis

Lévis, Quebec G6V 3Z1, Canada

Gerald Bronfman Centre for Clinical Research in Oncology

Montreal, Quebec H3A 1A1, Canada

Pardubicka krajska nemocnice, a.s.

Pardubice, Pardubice 532 03, Czechia

Fakultni nemocnice Na Bulovce

Budinova, Prague 180 00, Czechia

Oblastni nemocnice Pribram, a.s.

Příbram, Pribram 261 95, Czechia

Institut Onkologie a Rehabilitace Na Plesi

Nová Ves pod Pleší, 262 04, Czechia

Vitkovicka nemocnice a.s.

Ostrava, 700 30, Czechia

Fakultni Nemocnice Ostrava

Ostrava, 708 52, Czechia

Fakultni Nemocnice Kralovske Vinohrady

Prague, 100 00, Czechia

Fakultni nemocnice v Motole, s.p.

Prague, 150 06, Czechia

Nemocnice Tabor, a.s.

Tábor, 390 03, Czechia

CHU Angers

Angers, Angers Cedex 49933, France

Centre Francois Baclesse

Caen, Caen Cedex 14076, France

Centre d'Oncology de Gentilly

Cedex, Cedex 54100, France

Hopital Cardiologique, Chru Lille

Lille, Cedex 590, France

CHU Pontchaillou

Rennes, Cedex 35033, France

CRLCC René Gauducheau

Saint-Herblain, Cedex 44805, France

CLCC Paul Strauss

Strasbourg, Cedex 67085, France

Hopital Larrey

Toulouse, Cedex 31059, France

Centre Hospitalier du Mans

Le Mans, Le Mans Cedex 72037, France

Centre Léon Berard

Lyon, Lyon 69008, France

Centre Catherine de Sienne

Eric Tabarly, Nantes 44202, France

Hôpital Saint-Antoine

Paris, Paris 75012, France

Hopital Maison Blanche

Reims, Reims 51100, France

CHU de Nancy, Hopital de Brabois

Vandœuvre-lès-Nancy, Vandoeuvre Les Nancy 54500, France

Hopital Morvan

Brest, 29200, France

Hopital Sainte Marguerite

Marseille, 13274, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Praxis fuer interdisziplinaere Onkologie

Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany

Universitaetsklinikum Mannheim

Mannheim, Baden-Wurttemberg 68167, Germany

Universitaetsklinikum Erlangen - PS

Erlangen, Bavaria 91054, Germany

Asklepios Fachkliniken Muenchen-Gauting

Gauting, Bavaria 82131, Germany

Klinikum rechts der Isar der TU Muenchen

Munich, Bavaria 81675, Germany

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Heidelberg 69126, Germany

Gemeinschaftspraxis fuer Haematologie Onkologie

Wiesbaden, Hesse 65191, Germany

Universitaetsklinikum Goettingen

Göttingen, Lower Saxony 37075, Germany

St. Johannes Hospital - PS

Dortmund, North Rhine-Westphalia 44137, Germany

Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, Saxony-Anhalt 06120, Germany

Krankenhaus Grosshansdorf

Woehrendamm, Schleswig-Holstein 22927, Germany

Zentralklinik Bad Berka

Bad Berka, Thuringia 99437, Germany

General Hospital of Athens "Sotiria"

Athens, Athens 11527, Greece

University Hospital of Heraklio

Crete, Crete 71110, Greece

General Hospital of Chania 'Ag. Georgios'

Mourniés, Crete 73300, Greece

University Hospital of Larissa

Mezourlo, Larissa 411 10, Greece

University General Hospital of Patras

Rio, Patras 26505, Greece

General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, Greece

Semmelweis Egyetem

Budapest, Budapest 1125, Hungary

Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, Budapest 1529, Hungary

Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi

Csabai Kapu, Miskolc 3529, Hungary

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, Miskolc 3526, Hungary

Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz

Nyiregyháza, Nyiregyháza 4412, Hungary

Fejer Megyei Szent Gyorgy Korhaz

Seregelyesi, Szekesfehervar 8000, Hungary

Torokbalinti Tudogyogyintezet

Törökbálint, Torokbalint 2045, Hungary

Zala Megyei Korhaz

Zalaegerszeg, Zalaegerszeg 8900, Hungary

King George Hospital

Vishakhapattanam, Andhhra Pradesh 530002, India

Apollo Hospital

Hyderabad, Andhra Pradesh 500033, India

Indo-American Cancer Institute and Research Center

Hyderabad, Andhra Pradesh 500034, India

Kidwai Institute of Oncology

Bangalore, Karnataka 560029, India

M. S. Ramaiah Memorial Hospital

Bangalore, Karnataka 560054, India

A.J. Medical College Hosptial

Mangalore, Karnataka 575001, India

Tata Memorial Hospital

Mumbai, Maharashtra 400 012, India

P.D. Hinduja Nat. Hospital & Med. Research Centre

Mumbai, Maharashtra 400016, India

Kaushalya Medical Foundation Trust Hospital

Mumbai, Maharashtra 400601, India

Cancer Care Clinic

Nagpur, Maharashtra 440012, India

Shatabdi Hospital

Nashik, Maharashtra 422005, India

Deenanath Mangeshkar Hospital and Research Center

Pune, Maharashtra 411 004, India

Searoc Cancer Hospital

Jaipur, Rajasthan 302013, India

Mahaveer Cancer Hospital and Research Centre

Jaipur, Rajasthan 302017, India

Dr. Kamakshi Memorial Hospital Pvt Ltd

Chennai, Tamil Nadu 600100, India

Christian Medical College Hospital

Vellore, Tamil Nadu 632002, India

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

Ancona, AN 60020, Italy

CRO Centro di Riferimento Oncologico di Aviano

Aviano, Aviano 33081, Italy

Istituto per la Ricerca e la Cura del Cancro

Candiolo, Candiolo/TO 10060, Italy

Azienda Ospedaliera Istituti Ospitalieri di Cremona

Cremona, Cremona 26100, Italy

Ospedale Versilia

Lido di Camaiore, LU 55043, Italy

Istituto Nazionale Tumori

Milan, MI 20133, Italy

Azienda Ospedaliera San Gerardo

Monza, MI 20052, Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, RM, Italy

Ospedale Mater Salutis

Legnago, VR 37045, Italy

Dr. Anna Levcenko GP and Internist Practice

Daugavpils, LV-5403, Latvia

Piejuras Hospital

Liepāja, LV-4301, Latvia

Riga Eastern Clinical University Hospital

Riga, LV-1079, Latvia

P. Stradina Clinical University Hospital

Riga, LV1002, Latvia

Nilai Cancer Institute (NCI Cancer Hospital)

Negeri Sembilan, Darul Khusus 71800, Malaysia

Lam Wah Ee Hospital

Pulau Pinang, Georgetown, 11600, Malaysia

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan 16150, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Pahang 25100, Malaysia

St. Luke's Medical Center

Quezon City, Quezon City 1102, Philippines

Manila Doctors Hospital

Manila, 1000, Philippines

Lung Center of the Philippines

Quezon City, 1100, Philippines

Akademickie Centrum Kliniczne - Szpital AM w Gdansku

Gdansk, Gdansk 80-952, Poland

Nzoz Vesalius

Krakow, Krakow 31-108, Poland

Miedziowe Centrum Zdrowia S.A.

Lubin, Lubin 59-301, Poland

NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o

Olsztyn, Olsztyn 10-513, Poland

Specjalistyczny Szpital im. Prof. A. Sokolowskiego

Szczecin, Szczecin 70-891, Poland

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

Warsaw, Warszawa 02-781, Poland

Spitalul Judetean de Urgenta Braila

Brăila, Brăila County 810325, Romania

S.C. Ianuli Med Consult S.R.L.

Bucharest, Bucharest 020962, Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

Str. Republicii Nr. 34-36, Cluj-Napoca 400015, Romania

Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava

Suceava, Suceava 720237, Romania

Spitalul Judetean de Urgenta "Dr. Constantin Opris"

Baia Mare, 430031, Romania

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

Cluj-Napoca, 400015, Romania

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Arkhangelskaya oblast 163045, Russia

SHI Altay Regional Oncology Dispensary

Barnaul, Barnaul 656052, Russia

CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"

Moscow, Moscow 129128, Russia

City Clinical Hospital #1

Novosibirsk, Novosibirsk Oblast 630047, Russia

Perm Territorial Oncology Dispensary

Perm, Perm Krai 614066, Russia

SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"

Saint Petersburg, Sankt-Peterburg 197022, Russia

Oncology Dispensary #2 of Krasnodar Region

Dagomysskaya Str., Sochi 354057, Russia

National Cancer Centre

Hospital Drive, Singapore 169610, Singapore

Parkway Cancer Centre

Mount Elizabeth, Singapore 258500, Singapore

Medical Oncology Centre

Napier Road, Singapore 258500, Singapore

John Hopkins Singapore International Medical Centre

Singapore, 308433, Singapore

Chonnam National University Hwasun Hospital

Hwasun Up, Chonnam 519-809, South Korea

National Cancer Center

Ilsandong-gu, Goyang 411-769, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 463-707, South Korea

Samsung Medical Center

Gangnam-Gu, Seoul 135-710, South Korea

Seoul National University Hospital

Jongno-gu, Seoul 110-744, South Korea

Korea University Anam Hospital

Seongbuk-gu, Seoul 136-705, South Korea

Asan Medical Center

Songpa-gu, Seoul 138-736, South Korea

The Catholic University of Korea St. Vincent's Hospital

Paldal-gu, Suwon Gyeonggi-do 442-723, South Korea

H Mutua de Terrassa

Barcelona, Barcelona 08221, Spain

HU Virgen de las Nieves

Granada, Granada 18014, Spain

Fundacion Jimenez Diaz

Madrid, Madrid 28040, Spain

HGU La Paz

Madrid, Madrid 28046, Spain

Clinica Universitaria de Navarra

Pamplona, Pamplona 31008, Spain

Changhua Christian Hospital

Changhua, Changhua 500, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Kaohsiung 813, Taiwan

Taichung Veterans General Hospital

Taichung, Taichung 403, Taiwan

National Cheng Kung University Hospital

Tainan, Tainan 70428, Taiwan

Taipei Veterans General Hospital

Taipei, Taipei 112, Taiwan

Chang-Gung Memorial Hospital, Linkou Branch

Toayuan, Toayuan 333, Taiwan

Gazi University Medical Faculty

Ankara, Ankara 06500, Turkey (Türkiye)

Gaziantep University Medical Faculty

Gaziantep, Gaziantep, Turkey (Türkiye)

Istanbul Bilim University Medical Fac.

Istanbul, 34394, Turkey (Türkiye)

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Bristol Haematology & Oncology Centre

Bristol, Brist BS2 8ED, United Kingdom

Guy's & St Thomas' NHS Foundation Trust

London, Gt Lon SE1 9RT, United Kingdom

Christie Hospital

Manchester, Gt Man M20 4BX, United Kingdom

Southampton General Hospital

Southampton, Hants SO16 6YD, United Kingdom

Castle Hill Hospital

Cottingham Hull, Hull HU16 5JQ, United Kingdom

University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital

Wythenshawe, Manchester M23 9LT, United Kingdom

Singleton Hospital

Swansea, S Glam, SA2 8QA, United Kingdom

University Hospital of North Staffordshire

Stoke-on-Trent, Staffs ST4 7LN, United Kingdom

Wolverhampton New Cross Hospital

Wolverhampton, Staffs WV10 0QP, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, Strath G12 0YN, United Kingdom

Ninewells Hospital

Dundee, Tays DD1 9SY, United Kingdom

University Hospital of Coventry and Warwickshire

Coventry, Warwks CV2 2DX, United Kingdom