Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
NCT ID: NCT01166542
Last Updated: 2014-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
167 participants
INTERVENTIONAL
2010-06-30
2014-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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REOLYSIN, paclitaxel, carboplatin
REOLYSIN
3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
Carboplatin
5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
Paclitaxel
175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle
placebo, paclitaxel, carboplatin
Carboplatin
5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
Paclitaxel
175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle
Placebo
Placebo
Interventions
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REOLYSIN
3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
Carboplatin
5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
Paclitaxel
175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* have at least one lesion that is measurable by computed tomography or magnetic resonance imaging (Lesions persisting in previously treated radiation fields are considered not evaluable for response except if representing a relapse in a mucosal or nodal lesion that previously demonstrated a complete response. Any new lesion within the previous radiation fields is acceptable for determination of response and/or progression).
* have completed first line chemotherapy for R/M SCCHN which progressed on or within 190 days following the completion of platinum or platinum-based chemotherapy.
* have no continuing acute toxic effects (except alopecia) of any prior radiotherapy, chemotherapy, or surgical procedures. Any surgery involving the SCC for which the patient is being treated (except biopsies) must have occurred at least 28 days prior to study enrollment.
* have received no chemotherapy, radiotherapy, immunotherapy or hormonal therapy within 28 days.
* have ECOG Performance Score of ≤ 2.
* have life expectancy of at least 3 months.
* absolute neutrophil count (ANC)≥ 1.5 x 10\^9/L ; platelets ≥100 x 10\^9/L\]; hemoglobin ≥9.0 g/dL; serum creatinine ≤1.5 xULN; bilirubin ≤1.5 x ULN; AST/ALT ≤2.5 x ULN.
* negative pregnancy test for females with childbearing potential.
* Be wiling and able to comply with scheduled visits, the treatment plan, and laboratory tests.
Exclusion Criteria
* have been treated with a taxane for SCCHN.
* have current -- or with a history of -- brain metastases because of their poor prognosis and because of the frequent development of progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* be on chronic immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
* be a pregnant or breast-feeding woman. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. Barrier methods are a recommended form of contraception.
* have clinically significant cardiac disease (New York Heart Association, Class III or IV) including, but not limited to, pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 1 year prior to study entry.
* have dementia or any altered mental status that would prohibit informed consent.
* have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.
18 Years
ALL
No
Sponsors
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Oncolytics Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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James A Bonner, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham, Birmingham, AB, US
Kevin Harrington, MBBS MRCP FRCR
Role: PRINCIPAL_INVESTIGATOR
The Royal Marsden Hospital, London, UK
Jan Vermorken, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp, Belgium
Locations
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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
The 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
Antwerp, , 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
Pécs, , 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
Wojewódzki Szpital Specjalistyczny im. M.Kopernika
Lodz, , Poland
Szpital MSWiA - Centrum Onkologi
Olsztyn, , Poland
Wielkopolskie Centrum Onkologii
Poznan, , Poland
State Health Care Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, , Russia
Regional State Health Care Institution "Belgorod Oncology Dispensary"
Belgorod, , Russia
State Health Care Institution "Chelyabinsk Regional Oncology Dispensary"
Chelyabinsk, , Russia
State Health Care Institution "Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan"
Kazan', , Russia
State Budgetary Health Care Institution "Clinical Oncology Dispensary #1" of Krasnodar Region Health Care Department
Krasnodar, , Russia
Regional Budgetary Health Care Institution "Kursk Regional Oncology Dispensary" of Health Care Committee of Kursk region
Kursk, , Russia
Federal State Budgetary Institution "Medical Research Radiology Center" of Ministry of Public Health and Social Development of Russian Federation, Obninsk
Obninsk, , Russia
Federal State Budgetary Institution "N. N. Petrov Oncology Research Institute" of Ministry of Public Health and Social Development of the Russian Federation
Saint Petersburg, , Russia
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, , Russia
St.Petersburg State Health Care Institution City Clinical Oncology Dispensary"
Saint Petersburg, , Russia
State Health Care Institution "Oncology Dispensary №2" of Krasnodar Region Health Care Department
Sochi, , Russia
State Health Care Institution "Tula Regional Oncology Dispensary"
Tula, , Russia
State Budgetary Healthcare Institution "Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan"
Ufa, , Russia
State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Oncological Hospital"
Yaroslavl, , Russia
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
Clatterbridge Centre for Oncology NHS Foundation Trust
Metropolitan Borough of Wirral, , United Kingdom
The Royal Marsden Cancer Center, Sutton Branch
Sutton, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
The Velindre Hospital
Whitchurch, , United Kingdom
Countries
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Other Identifiers
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REO 018
Identifier Type: -
Identifier Source: org_study_id
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