Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers

PHASE3CompletedINTERVENTIONAL
Enrollment

167

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

April 30, 2012

Study Completion Date

May 31, 2014

Conditions
Carcinoma, Squamous Cell of the Head and Neck
Interventions
BIOLOGICAL

REOLYSIN

3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle

DRUG

Carboplatin

5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle

DRUG

Paclitaxel

175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle

DRUG

Placebo

Placebo

Trial Locations (77)

1090

Universitair Ziekenhuis Brussel, Jette

10467

Montefiore Medical Center, The Bronx

21231

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

29425

Medical University of South Carolina, Charleston

30322

Emory University - Winship Cancer Institute, Altanta

33075

Hopital Saint-André / Service d'Oncologie-Radiothérapie, Bordeaux

34652

Pasco Hernando Oncology Associates, PA, New Port Richey

35233

University of Alabama at Birmingham, Birmingham

43623

Mercy Cancer Center, Toledo

44106

Case Comprehensive Cancer Center, University Hospitals Case Medical Center, Cleveland

59169

Comprehensive Cancer Centers of Nevada, Las Vegas

60007

Alexian Brothers Hospital Network, Elk Grove Village

70809

Mary Bird Perkinds Cancer Center - Baton Rouge, Baton Rouge

75246

Texas Oncology- Sammons Cancer Center, Dallas

75248

Institut Curie / Département d'Oncologie Médicale, Paris

75702

Texas Oncology - Tyler, Tyler

78229

Cancer Therapy and Research Center at UTHSCSA, San Antonio

80218

Rocky Mountain Cancer Centers, Denver

85715

Arizona Oncology Associates, Tucson

91505

Providence Health and Services, Burbank

92868

BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates, Orange

92879

Wilshire Oncology Medical Group, Corona

99336

Columbia Basin Hematology and Oncology, Kennewick

02115

Dana-Farber Cancer Institute, Boston

Unknown

ZNA Middelheim, Antwerp

University Hospital Antwerp, Edegem

UKE Hamburg, Hamburg

Attikon University Hospital, Athens

Fovarosi Onkormanyzat Uzsoki Utcai Kórház, Budapest

Orszagos Onkologiai Intezet, Budapest

Pecsi Tudomanyegyetem, Pécs

Szegedi Tudományegyetem, Szegedi

Markusovszky Korhaz, Szombathely

Ufficio Sperimentazioni Cliniche c/o S.C. Oncologia Medica, Cuneo

Fondazione IRCCS Istituto Nazionale del Tumori, Milan

Ospedale San Paolo - Oncologia Medica, Milan

University Hospital in Modena, Modena

Centrum Onkologii - Instytyt im.M.Skłodowskiej-Curie, Krakow

Wojewódzki Szpital Specjalistyczny im. M.Kopernika, Lodz

Szpital MSWiA - Centrum Onkologi, Olsztyn

Wielkopolskie Centrum Onkologii, Poznan

"State Health Care Institution Arkhangelsk Regional Clinical Oncology Dispensary", Arkhangelsk

"Regional State Health Care Institution Belgorod Oncology Dispensary", Belgorod

"State Health Care Institution Chelyabinsk Regional Oncology Dispensary", Chelyabinsk

"State Health Care Institution Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan", Kazan'

"State Budgetary Health Care Institution Clinical Oncology Dispensary #1 of Krasnodar Region Health Care Department", Krasnodar

"Regional Budgetary Health Care Institution Kursk Regional Oncology Dispensary of Health Care Committee of Kursk region", Kursk

"Federal State Budgetary Institution Medical Research Radiology Center of Ministry of Public Health and Social Development of Russian Federation, Obninsk", Obninsk

"Federal State Budgetary Institution N. N. Petrov Oncology Research Institute of Ministry of Public Health and Social Development of the Russian Federation", Saint Petersburg

"Federal State Budgetary Institution Russian Research Centre of Radiology and Surgery technologies of Ministry of Public Health and Social Development of the Russian Federation", Saint Petersburg

"St.Petersburg State Health Care Institution City Clinical Oncology Dispensary", Saint Petersburg

"State Health Care Institution Oncology Dispensary №2 of Krasnodar Region Health Care Department", Sochi

"State Health Care Institution Tula Regional Oncology Dispensary", Tula

"State Budgetary Healthcare Institution Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan", Ufa

"State Budgetary Health Care Institution of the Yaroslavl region Regional Clinical Oncological Hospital", Yaroslavl

Institute of Oncology Ljubljana, Ljubljana

Hospital Clinic i Provincial de Barcelona, Barcelona

Hospital Santa Creu I Sant Pau, Barcelona

Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol, Barcelona

Hospital de Basurto, Bilbao

Hospital de Navarra, Pamplona

T2N 4N2

Tom Baker Cancer Centre, Calgary

L8V 5C2

Juravinski Cancer Center, Hamilton

N6A 4L6

London Health Sciences Centre, London

H2L 4M1

Hopital Notre-Dame, Montreal

06189

Centre Antoine Lacassagne / Oncologie Médicale, Nice

08035

Hospital Vall D'Hebron, Barcelona

08908

Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals, Barcelona

G12 0YN

Beatson West of Scotland Cancer Center, Glasgow

GU2 7WG

Royal Surrey County Hospital, Guildford

LS9 7TF

St. James's University Hospital, Leeds

SE1 9RT

Guy's and St. Thomas Hospital, London

SW3 6JJ

The Royal Marsden Cancer Center, Fulham Road branch, London

CH634JY

Clatterbridge Centre for Oncology NHS Foundation Trust, Metropolitan Borough of Wirral

SM2 5PT

The Royal Marsden Cancer Center, Sutton Branch, Sutton

TA1 5DA

Musgrove Park Hospital, Taunton

CF14 2TL

The Velindre Hospital, Whitchurch

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Oncolytics Biotech

INDUSTRY