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Spots Global Cancer Trial Database for Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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