Carcinoma, Squamous Cell of the Head and Neck Clinical Trial
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
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.
Status | Completed |
Enrollment | 167 |
Est. completion date | May 2014 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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. Exclusion Criteria: 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | ZNA Middelheim | Antwerpen | |
Belgium | University Hospital Antwerp | Edegem | |
Belgium | Universitair Ziekenhuis Brussel | Jette | |
Canada | 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 |
France | Hopital Saint-André / Service d'Oncologie-Radiothérapie | Bordeaux | |
France | Centre Antoine Lacassagne / Oncologie Médicale | Nice | |
France | Institut Curie / Département d'Oncologie Médicale | Paris | |
Germany | UKE Hamburg | Hamburg | |
Greece | Attikon University Hospital | Athens | |
Hungary | Fovarosi Onkormanyzat Uzsoki Utcai Kórház | Budapest | |
Hungary | Orszagos Onkologiai Intezet | Budapest | |
Hungary | Pecsi Tudomanyegyetem | Pecs | |
Hungary | Szegedi Tudományegyetem | Szegedi | |
Hungary | Markusovszky Korhaz | Szombathely | |
Italy | 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 | |
Poland | Centrum Onkologii - Instytyt im.M.Sklodowskiej-Curie | Krakow | |
Poland | Wojewódzki Szpital Specjalistyczny im. M.Kopernika | Lódz | |
Poland | Szpital MSWiA - Centrum Onkologi | Olsztyn | |
Poland | Wielkopolskie Centrum Onkologii | Poznan | |
Russian Federation | 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 | |
Slovenia | Institute of Oncology Ljubljana | Ljubljana | |
Spain | Hospital Clinic i Provincial de Barcelona | Barcelona | |
Spain | Hospital Santa Creu I Sant Pau | Barcelona | |
Spain | Hospital Vall D'Hebron | Barcelona | |
Spain | Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals | Barcelona | |
Spain | Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol | Barcelona | |
Spain | Hospital de Basurto | Bilbao | |
Spain | Hospital de Navarra | Pamplona | |
United Kingdom | 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 States | Emory University - Winship Cancer Institute | Altanta | Georgia |
United States | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
United States | Mary Bird Perkinds Cancer Center - Baton Rouge | Baton Rouge | Louisiana |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Providence Health and Services | Burbank | California |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Case Comprehensive Cancer Center, University Hospitals Case Medical Center | Cleveland | Ohio |
United States | Wilshire Oncology Medical Group | Corona | California |
United States | Texas Oncology- Sammons Cancer Center | Dallas | Texas |
United States | Rocky Mountain Cancer Centers | Denver | Colorado |
United States | Alexian Brothers Hospital Network | Elk Grove Village | Illinois |
United States | Columbia Basin Hematology and Oncology | Kennewick | Washington |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Pasco Hernando Oncology Associates, PA | New Port Richey | Florida |
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 | Mercy Cancer Center | Toledo | Ohio |
United States | Arizona Oncology Associates | Tucson | Arizona |
United States | Texas Oncology - Tyler | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
Oncolytics Biotech |
United States, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Poland, Russian Federation, Slovenia, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | every 3 months until death. | No | |
Secondary | Progression-free survival | Assessed every 6 weeks until disease progression or death. | No | |
Secondary | 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. | No | |
Secondary | 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. | Yes | |
Secondary | 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. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00753038 -
Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT02573493 -
Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)
|
Phase 2 |