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Brief Title: Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
Official Title: Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase 3 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin Versus the Chemotherapy Alone in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck Who Have Progressed on or After Prior Platinum-Based Chemotherapy
Study ID: NCT01166542
Brief Summary: The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.
Detailed Description: Squamous cell carcinoma of the head and neck is the sixth most common cancer in the world. More than 50% of patients diagnosed with advanced regional disease will relapse locally or at distant sites. Initial therapeutic options include irradiation, surgery and chemotherapy. The most commonly used agents are cisplatin and carboplatin, generally in combination with 5-FU or a taxane. Erbitux has been approved for use in first-line with radiation and in second-line as monotherapy. Only about a third of the patients will respond to first-line platinum-based therapy and the median overall survival is about 6-9 months. Preliminary assessment of a Phase 1-2 study conducted in the UK investigating the combination of REOLYSIN, carboplatin and paclitaxel suggested that patients with head and neck carcinomas may represent a group of patients in whom this treatment combination is active. Studies have also shown that paclitaxel and carboplatin combination therapy may be effective in head and neck cancers, even in heavily pretreated patients and those resistant to previous treatment. These results strongly support the utility of the carboplatin/paclitaxel combination as a control arm for salvage therapy in platinum refractory patients, a patient group with few and poor treatment options and with no gold standard therapy. This Phase 3 study is designed to compare response rates following intravenous administration of REOLYSIN (Reovirus Type 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck. Overall survival is a primary endpoint of this trial. Patients will be clinically evaluated after each course of treatment and radiologically every 6 weeks on and after treatment. The safety of the paclitaxel and carboplatin with intravenous blinded placebo or intravenous blinded REOLYSIN will also be assessed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Oncology Associates, Tucson, Arizona, United States
Providence Health and Services, Burbank, California, United States
Wilshire Oncology Medical Group, Corona, California, United States
BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates, Orange, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Pasco Hernando Oncology Associates, PA, New Port Richey, Florida, United States
Emory University - Winship Cancer Institute, Altanta, Georgia, United States
Alexian Brothers Hospital Network, Elk Grove Village, Illinois, United States
Mary Bird Perkinds Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Montefiore Medical Center, Bronx, New York, United States
Case Comprehensive Cancer Center, University Hospitals Case Medical Center, Cleveland, Ohio, United States
Mercy Cancer Center, Toledo, Ohio, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Texas Oncology- Sammons Cancer Center, Dallas, Texas, United States
Cancer Therapy and Research Center at UTHSCSA, San Antonio, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
Columbia Basin Hematology and Oncology, Kennewick, Washington, United States
ZNA Middelheim, Antwerpen, , Belgium
University Hospital Antwerp, Edegem, , Belgium
Universitair Ziekenhuis Brussel, Jette, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Juravinski Cancer Center, Hamilton, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
Hopital Notre-Dame, Montreal, Quebec, Canada
Hopital Saint-André / Service d'Oncologie-Radiothérapie, Bordeaux, , France
Centre Antoine Lacassagne / Oncologie Médicale, Nice, , France
Institut Curie / Département d'Oncologie Médicale, Paris, , France
UKE Hamburg, Hamburg, , Germany
Attikon University Hospital, Athens, , Greece
Fovarosi Onkormanyzat Uzsoki Utcai Kórház, Budapest, , Hungary
Orszagos Onkologiai Intezet, Budapest, , Hungary
Pecsi Tudomanyegyetem, Pecs, , Hungary
Szegedi Tudományegyetem, Szegedi, , Hungary
Markusovszky Korhaz, Szombathely, , Hungary
Ufficio Sperimentazioni Cliniche c/o S.C. Oncologia Medica, Cuneo, , Italy
Fondazione IRCCS Istituto Nazionale del Tumori, Milan, , Italy
Ospedale San Paolo - Oncologia Medica, Milan, , Italy
University Hospital in Modena, Modena, , Italy
Centrum Onkologii - Instytyt im.M.Skłodowskiej-Curie, Krakow, , Poland
Szpital MSWiA - Centrum Onkologi, Olsztyn, , Poland
Wielkopolskie Centrum Onkologii, Poznań, , Poland
Wojewódzki Szpital Specjalistyczny im. M.Kopernika, Łódź, , Poland
State Health Care Institution "Arkhangelsk Regional Clinical Oncology Dispensary", Arkhangelsk, , Russian Federation
Regional State Health Care Institution "Belgorod Oncology Dispensary", Belgorod, , Russian Federation
State Health Care Institution "Chelyabinsk Regional Oncology Dispensary", Chelyabinsk, , Russian Federation
State Health Care Institution "Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan", Kazan, , Russian Federation
State Budgetary Health Care Institution "Clinical Oncology Dispensary #1" of Krasnodar Region Health Care Department, Krasnodar, , Russian Federation
Regional Budgetary Health Care Institution "Kursk Regional Oncology Dispensary" of Health Care Committee of Kursk region, Kursk, , Russian Federation
Federal State Budgetary Institution "Medical Research Radiology Center" of Ministry of Public Health and Social Development of Russian Federation, Obninsk, Obninsk, , Russian Federation
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, , Russian Federation
Federal State Budgetary Institution "N. N. Petrov Oncology Research Institute" of Ministry of Public Health and Social Development of the Russian Federation, Saint-Petersburg, , Russian Federation
St.Petersburg State Health Care Institution City Clinical Oncology Dispensary", Saint-Petersburg, , Russian Federation
State Health Care Institution "Oncology Dispensary №2" of Krasnodar Region Health Care Department, Sochi, , Russian Federation
State Health Care Institution "Tula Regional Oncology Dispensary", Tula, , Russian Federation
State Budgetary Healthcare Institution "Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan", Ufa, , Russian Federation
State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Oncological Hospital", Yaroslavl, , Russian Federation
Institute of Oncology Ljubljana, Ljubljana, , Slovenia
Hospital Vall D'Hebron, Barcelona, , Spain
Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Santa Creu I Sant Pau, Barcelona, , Spain
Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol, Barcelona, , Spain
Hospital de Basurto, Bilbao, , Spain
Hospital de Navarra, Pamplona, , Spain
Beatson West of Scotland Cancer Center, Glasgow, , United Kingdom
Royal Surrey County Hospital, Guildford, , United Kingdom
St. James's University Hospital, Leeds, , United Kingdom
Guy's and St. Thomas Hospital, London, , United Kingdom
The Royal Marsden Cancer Center, Fulham Road branch, London, , United Kingdom
The Royal Marsden Cancer Center, Sutton Branch, Sutton, , United Kingdom
Musgrove Park Hospital, Taunton, , United Kingdom
The Velindre Hospital, Whitchurch, , United Kingdom
Clatterbridge Centre for Oncology NHS Foundation Trust, Wirral, , United Kingdom
Name: James A Bonner, MD
Affiliation: University of Alabama at Birmingham, Birmingham, AB, US
Role: PRINCIPAL_INVESTIGATOR
Name: Kevin Harrington, MBBS MRCP FRCR
Affiliation: The Royal Marsden Hospital, London, UK
Role: PRINCIPAL_INVESTIGATOR
Name: Jan Vermorken, MD, PhD
Affiliation: University Hospital, Antwerp, Belgium
Role: PRINCIPAL_INVESTIGATOR