Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
- Conditions
- Carcinoma, Squamous Cell of the Head and Neck
- Interventions
- Registration Number
- NCT01166542
- Lead Sponsor
- Oncolytics Biotech
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
Each patient MUST:
- have recurrent or metastatic (R/M) histologically confirmed squamous cell carcinoma (SCC) of the head and neck (oropharynx, oral cavity, larynx, hypopharynx) or squamous cell nasopharynx cancer (NPC) with distal metastasis(es) and no secondary cancers (Patients with NPC without distal metastasis(es) or with undifferentiated NPC are not eligible).
- 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.
No patient may:
- receive concurrent therapy with any other investigational anticancer agent while on study.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description REOLYSIN, paclitaxel, carboplatin REOLYSIN - placebo, paclitaxel, carboplatin Placebo - REOLYSIN, paclitaxel, carboplatin Paclitaxel - REOLYSIN, paclitaxel, carboplatin Carboplatin - placebo, paclitaxel, carboplatin Carboplatin - placebo, paclitaxel, carboplatin Paclitaxel -
- Primary Outcome Measures
Name Time Method Overall survival every 3 months until death.
- Secondary Outcome Measures
Name Time Method Progression-free survival Assessed every 6 weeks until disease progression or death. Objective response (complete response (CR) + partial response (PR)) rate and duration Evaluation of response is conducted every 6 weeks on and after study. Duration of objective response is measured from the time measurement criteria are first met for CR or PR until recurrent or progressive disease is objectively documented. Number of participants with adverse events as a measure of safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin. Within 30 days of the last dose of REOLYSIN. Compare Best % Tumor Specific Response in loco-regional disease and/or metastatic disease for the treatment regimens in the study population Assessed every 6 weeks until disease progression or death.
Trial Locations
- Locations (77)
Case Comprehensive Cancer Center, University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Wilshire Oncology Medical Group
🇺🇸Corona, California, 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
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Texas Oncology- Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Columbia Basin Hematology and Oncology
🇺🇸Kennewick, Washington, United States
Attikon University Hospital
🇬🇷Athens, Greece
Wielkopolskie Centrum Onkologii
🇵🇱Poznań, Poland
Hospital Vall D'Hebron
🇪🇸Barcelona, Spain
Guy's and St. Thomas Hospital
🇬🇧London, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Mary Bird Perkinds Cancer Center - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
State Budgetary Healthcare Institution "Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan"
🇷🇺Ufa, Russian Federation
State Health Care Institution "Tula Regional Oncology Dispensary"
🇷🇺Tula, Russian Federation
Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Regional State Health Care Institution "Belgorod Oncology Dispensary"
🇷🇺Belgorod, Russian Federation
State Health Care Institution "Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan"
🇷🇺Kazan, 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 "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
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Szpital MSWiA - Centrum Onkologi
🇵🇱Olsztyn, Poland
Institute of Oncology Ljubljana
🇸🇮Ljubljana, Slovenia
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Szegedi Tudományegyetem
🇭🇺Szegedi, Hungary
Hospital de Basurto
🇪🇸Bilbao, Spain
Providence Health and Services
🇺🇸Burbank, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates
🇺🇸Orange, California, United States
Cancer Therapy and Research Center at UTHSCSA
🇺🇸San Antonio, Texas, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
ZNA Middelheim
🇧🇪Antwerpen, Belgium
University Hospital Antwerp
🇧🇪Edegem, Belgium
Juravinski Cancer Center
🇨🇦Hamilton, Ontario, Canada
Hopital Saint-André / Service d'Oncologie-Radiothérapie
🇫🇷Bordeaux, France
Centre Antoine Lacassagne / Oncologie Médicale
🇫🇷Nice, France
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Institut Curie / Département d'Oncologie Médicale
🇫🇷Paris, France
UKE Hamburg
🇩🇪Hamburg, Germany
Universitair Ziekenhuis Brussel
🇧🇪Jette, Belgium
Orszagos Onkologiai Intezet
🇭🇺Budapest, Hungary
Fovarosi Onkormanyzat Uzsoki Utcai Kórház
🇭🇺Budapest, Hungary
Ufficio Sperimentazioni Cliniche c/o S.C. Oncologia Medica
🇮🇹Cuneo, Italy
Pecsi Tudomanyegyetem
🇭🇺Pecs, Hungary
Markusovszky Korhaz
🇭🇺Szombathely, Hungary
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
🇵🇱Łódź, Poland
State Health Care Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
🇷🇺Arkhangelsk, Russian Federation
State Budgetary Health Care Institution "Clinical Oncology Dispensary #1" of Krasnodar Region Health Care Department
🇷🇺Krasnodar, Russian Federation
State Health Care Institution "Oncology Dispensary №2" of Krasnodar Region Health Care Department
🇷🇺Sochi, Russian Federation
State Health Care Institution "Chelyabinsk Regional Oncology Dispensary"
🇷🇺Chelyabinsk, 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 "Russian Research Centre of Radiology and Surgery technologies" of Ministry of Public Health and Social Development of the Russian Federation
🇷🇺Saint Petersburg, Russian Federation
Beatson West of Scotland Cancer Center
🇬🇧Glasgow, United Kingdom
Hospital Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol
🇪🇸Barcelona, Spain
State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Oncological Hospital"
🇷🇺Yaroslavl, Russian Federation
St. James's University Hospital
🇬🇧Leeds, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom
The Velindre Hospital
🇬🇧Whitchurch, United Kingdom
Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals
🇪🇸Barcelona, Spain
The Royal Marsden Cancer Center, Sutton Branch
🇬🇧Sutton, United Kingdom
The Royal Marsden Cancer Center, Fulham Road branch
🇬🇧London, United Kingdom
Clatterbridge Centre for Oncology NHS Foundation Trust
🇬🇧Wirral, United Kingdom
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mercy Cancer Center
🇺🇸Toledo, Ohio, United States
Hospital de Navarra
🇪🇸Pamplona, Spain
Montefiore Medical Center
🇺🇸Bronx, New York, United States