Clinical trial NCT00707304: Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer
Official title: FORTIS-M: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Oral Talactoferrin in Addition to Best Supportive Care in Patients With Non-small Cell Lung Cancer Who Have Failed Two or More Prior Treatment Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
Talactoferrin
Dendritic Cell Recruiter and Activator
Immunomodulatory agent
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2008-06-30
Enrollment: 742
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 purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.


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

Primary outcomes:
measure: Overall survival
timeFrame: After the occurence of the required number of events
Secondary outcomes:
measure: Progression free survival
timeFrame: At time of final analysis
measure: Objective response and disease stablization rate
timeFrame: At time of final analysis
measure: Safety and tolerability
timeFrame: At time of final analysis
Other outcomes:
Locations:
city: Casa Grande
country: United States
facility: Desert Oasis Cancer Center
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Port Richey
country: United States
facility: Pasco Pinellas Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Central Illinois
state: Illinois
city: Niles
country: United States
facility: Cancer Care & Hematology Specialists of Chicagoland
state: Illinois
city: Greenfield
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Center, LLC
state: Kansas
city: Bethesda
country: United States
facility: NCI, CCR, The Waren Grant Magnuson Clinical Center
state: Maryland
city: Southfield
country: United States
facility: Newland Medical Associates
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology and Hematology, PA
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Hooksett
country: United States
facility: NH Oncology-Hematology, PA
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Burlington
country: United States
facility: Alamance Regional Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Rex Cancer Center
state: North Carolina
city: Bismarck
country: United States
facility: Legacy Pharma Research
state: North Dakota
city: Middletown
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Kaiser Group Health
state: Oregon
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Salem
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Campbelltown
country: Australia
facility: Campbelltown Hospital
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
state: New South Wales
city: Townsville
country: Australia
facility: Townsville Hospital
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elisabeth Hospital
state: South Australia
city: Richmond
country: Australia
facility: Epworth Healthcare
state: Victoria
city: Aleksandur Stamboliyski
country: Bulgaria
facility: DDODIU-Plovdiv, EOOD
state: Plovdiv
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: DDODIU-Plovdiv, EOOD
city: Sofia
country: Bulgaria
facility: DDODIU - Sofia District EOOD
city: Sofia
country: Bulgaria
facility: UMHAT 'Tsaritsa Yoanna - ISUL', EAD
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Lévis
country: Canada
facility: Hôtel-Dieu de Lévis
state: Quebec
city: Montreal
country: Canada
facility: Gerald Bronfman Centre for Clinical Research in Oncology
state: Quebec
city: Budinova
country: Czech Republic
facility: Fakultni nemocnice Na Bulovce
state: Praha
city: Nova Ves pod Plesi
country: Czech Republic
facility: Institut Onkologie a Rehabilitace Na Plesi
city: Ostrava
country: Czech Republic
facility: Vitkovicka nemocnice a.s.
city: Ostrava
country: Czech Republic
facility: Fakultni Nemocnice Ostrava
city: Pardubice
country: Czech Republic
facility: Pardubicka krajska nemocnice, a.s.
city: Praha
country: Czech Republic
facility: Fakultni Nemocnice Kralovske Vinohrady
city: Praha
country: Czech Republic
facility: Fakultni nemocnice v Motole, s.p.
city: Pribram
country: Czech Republic
facility: Oblastni nemocnice Pribram, a.s.
city: Tabor
country: Czech Republic
facility: Nemocnice Tabor, a.s.
city: Lille
country: France
facility: Hopital Cardiologique, Chru Lille
state: Cedex
city: Rennes
country: France
facility: CHU Pontchaillou
state: Cedex
city: Saint-herblain
country: France
facility: CRLCC René Gauducheau
state: Cedex
city: Strasbourg
country: France
facility: CLCC Paul Strauss
state: Cedex
city: Toulouse
country: France
facility: Hopital Larrey
state: Cedex
city: Eric Tabarly
country: France
facility: Centre Catherine de Sienne
state: Nantes
city: Angers cedex
country: France
facility: CHU Angers
city: Brest
country: France
facility: Hopital Morvan
city: Caen Cedex
country: France
facility: Centre Francois Baclesse
city: Cedex
country: France
facility: Centre d'Oncology de Gentilly
city: Le Mans Cedex
country: France
facility: Centre Hospitalier du Mans
city: Lyon
country: France
facility: Centre Léon Berard
city: Marseille Cedex 9
country: France
facility: Hopital Sainte Marguerite
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Pierre Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: Hopital Maison Blanche
city: Vandoeuvre les Nancy
country: France
facility: CHU de Nancy, Hopital de Brabois
city: Freiburg
country: Germany
facility: Praxis fuer interdisziplinaere Onkologie
state: BW
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
state: BW
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen - PS
state: BY
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen-Gauting
state: BY
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der TU Muenchen
state: BY
city: Wiesbaden
country: Germany
facility: Gemeinschaftspraxis fuer Haematologie Onkologie
state: HE
city: Goettingen
country: Germany
facility: Universitaetsklinikum Goettingen
state: NI
city: Dortmund
country: Germany
facility: St. Johannes Hospital - PS
state: NW
city: Woehrendamm
country: Germany
facility: Krankenhaus Grosshansdorf
state: SH
city: Halle
country: Germany
facility: Staedt. Krankenhaus Martha-Maria Halle-Doelau gGmbH
state: ST
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
state: TH
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH
city: Mournies
country: Greece
facility: General Hospital of Chania 'Ag. Georgios'
state: Crete
city: Mezourlo
country: Greece
facility: University Hospital of Larissa
state: Larissa
city: Rion
country: Greece
facility: University General Hospital of Patras
state: Patras
city: Athens
country: Greece
facility: General Hospital of Athens "Sotiria"
city: Crete
country: Greece
facility: University Hospital of Heraklio
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
city: Csabai kapu
country: Hungary
facility: Miskolc Megyei Jogu Varos Onkormanyzat Miskolci Egeszsegugyi
state: Miskolc
city: Seregelyesi
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz
state: Szekesfehervar
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Koranyi TBC es Pulmonologiai Intezet
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Nyiregyháza
country: Hungary
facility: Szabolcs-Szatmar Bereg Megyei Josa Andras Oktato Korhaz
city: Torokbalint
country: Hungary
facility: Torokbalinti Tudogyogyintezet
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz
city: Vishakhapattanam
country: India
facility: King George Hospital
state: Andhhra Pradesh
city: Hyderabad
country: India
facility: Apollo Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Indo-American Cancer Institute and Research Center
state: Andhra Pradesh
city: Bangalore
country: India
facility: Kidwai Institute of Oncology
state: Karnataka
city: Bangalore
country: India
facility: M. S. Ramaiah Memorial Hospital
state: Karnataka
city: Mangalore
country: India
facility: A.J. Medical College Hosptial
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Mumbai
country: India
facility: P.D. Hinduja Nat. Hospital & Med. Research Centre
state: Maharashtra
city: Mumbai
country: India
facility: Kaushalya Medical Foundation Trust Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Cancer Care Clinic
state: Maharashtra
city: Nashik
country: India
facility: Shatabdi Hospital
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Center
state: Maharashtra
city: Jaipur
country: India
facility: Searoc Cancer Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Mahaveer Cancer Hospital and Research Centre
state: Rajasthan
city: Chennai
country: India
facility: Dr. Kamakshi Memorial Hospital Pvt Ltd
state: Tamilnadu
city: Vellore
country: India
facility: Christian Medical College Hospital
state: Tamilnadu
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
state: AN
city: Candiolo
country: Italy
facility: Istituto per la Ricerca e la Cura del Cancro
state: Candiolo/TO
city: Lido di Camaiore
country: Italy
facility: Ospedale Versilia
state: LU
city: Milano
country: Italy
facility: Istituto Nazionale Tumori
state: MI
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
state: MI
city: Roma,
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: RM
city: Legnago
country: Italy
facility: Ospedale Mater Salutis
state: VR
city: Aviano
country: Italy
facility: CRO Centro di Riferimento Oncologico di Aviano
city: Cremona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona
city: Hwasun up
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Chonnam
city: Ilsandong-gu
country: Korea, Republic of
facility: National Cancer Center
state: Goyang
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do,
city: Gangnam-Gu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
city: Jongno-gu
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul
city: Seongbuk-gu
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul
city: Paldal-gu
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
state: Suwon Gyeonggi-do
city: Daugavpils
country: Latvia
facility: Dr. Anna Levcenko GP and Internist Practice
city: Liepaja
country: Latvia
facility: Piejuras Hospital
city: Riga
country: Latvia
facility: Riga Eastern Clinical University Hospital
city: Riga
country: Latvia
facility: P. Stradina Clinical University Hospital
city: Negeri Sembilan
country: Malaysia
facility: Nilai Cancer Institute (NCI Cancer Hospital)
state: Darul Khusus
city: Pulau Pinang
country: Malaysia
facility: Lam Wah Ee Hospital
state: Georgetown,
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
state: Pahang
city: Manila
country: Philippines
facility: Manila Doctors Hospital
city: Quezon City
country: Philippines
facility: Lung Center of the Philippines
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Gdansk
country: Poland
facility: Akademickie Centrum Kliniczne - Szpital AM w Gdansku
city: Krakow
country: Poland
facility: Nzoz Vesalius
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia S.A.
city: Olsztyn
country: Poland
facility: NZOZ Olsztynski Osr. Onkologiczny "Kopernik" Sp.z o.o
city: Szczecin
country: Poland
facility: Specjalistyczny Szpital im. Prof. A. Sokolowskiego
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
city: Str. Republicii nr. 34-36
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
state: Cluj-Napoca
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris"
city: Braila
country: Romania
facility: Spitalul Judetean de Urgenta Braila
city: Bucuresti
country: Romania
facility: S.C. Ianuli Med Consult S.R.L.
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
city: Suceava
country: Romania
facility: Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
city: Dagomysskaya str.
country: Russian Federation
facility: Oncology Dispensary #2 of Krasnodar Region
state: Sochi
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
city: Barnaul
country: Russian Federation
facility: SHI Altay Regional Oncology Dispensary
city: Moscow
country: Russian Federation
facility: CCH #2 n.a. N. A. Semashko of LLC "Russian Railways"
city: Novosibirsk
country: Russian Federation
facility: City Clinical Hospital #1
city: Perm
country: Russian Federation
facility: Perm Territorial Oncology Dispensary
city: St. Petersburg
country: Russian Federation
facility: SEIHPE "Saint Petersburg SMU RosZdrav n.a. I.I.Pavlov"
city: Hospital Drive
country: Singapore
facility: National Cancer Centre
city: Mount Elizabeth
country: Singapore
facility: Parkway Cancer Centre
city: Napier Road
country: Singapore
facility: Medical Oncology Centre
city: Singapore
country: Singapore
facility: John Hopkins Singapore International Medical Centre
city: Barcelona
country: Spain
facility: H Mutua de Terrassa
city: Granada
country: Spain
facility: HU Virgen de las Nieves
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: HGU La Paz
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung,
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Toayuan
country: Taiwan
facility: Chang-Gung Memorial Hospital, Linkou Branch
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Bilim University Medical Fac.
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Bristol
country: United Kingdom
facility: Bristol Haematology & Oncology Centre
state: Brist
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
state: Gt Lon
city: Manchester
country: United Kingdom
facility: Christie Hospital
state: Gt Man
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hants
city: Cottingham Hull
country: United Kingdom
facility: Castle Hill Hospital
state: Hull
city: Wythenshawe
country: United Kingdom
facility: University Hospital of South Manchester NHS Foundation Trust Wythenshawe Hospital
state: Manchester
city: Swansea,
country: United Kingdom
facility: Singleton Hospital
state: S Glam,
city: Stoke on Trent
country: United Kingdom
facility: University Hospital of North Staffordshire
state: Staffs
city: Wolverhampton
country: United Kingdom
facility: Wolverhampton New Cross Hospital
state: Staffs
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Strath
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Tays
city: Coventry
country: United Kingdom
facility: University Hospital of Coventry and Warwickshire
state: Warwks
Study officials:
References: