Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers

NCT01166542 | Completed Phase 3 DMC

• 1 other identifier: REO 018
• Study Type: interventional
• Target: 167
• Locations: 13 countries
• Sites: 77

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.

Conditions

Carcinoma, Squamous Cell of the Head and Neck

Keywords

carcinoma; squamous cell; head; neck; REOLYSIN (Reovirus Type 3 Dearing); chemotherapy; Carboplatin; Paclitaxel; metastatic; recurrent

Outcome Measures

Primary Outcomes (1)

• Overall survival

  every 3 months until death.

Secondary Outcomes (4)

• 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.

Study Arms (2)

REOLYSIN, paclitaxel, carboplatin

ACTIVE COMPARATOR

Biological: REOLYSIN; Drug: Carboplatin; Drug: Paclitaxel

placebo, paclitaxel, carboplatin

PLACEBO COMPARATOR

Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo

Interventions

REOLYSIN BIOLOGICAL

3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle

Also known as: reovirus serotype 3 Dearing Strain

REOLYSIN, paclitaxel, carboplatin

Carboplatin DRUG

5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle

REOLYSIN, paclitaxel, carboplatin; placebo, paclitaxel, carboplatin

Paclitaxel DRUG

175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle

REOLYSIN, paclitaxel, carboplatin; placebo, paclitaxel, carboplatin

Placebo DRUG

Placebo

placebo, paclitaxel, carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oncolytics Biotech: lead

Study Sites (77)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Arizona Oncology Associates

Tucson, Arizona, 85715, United States

Location

Providence Health and Services

Burbank, California, 91505, United States

Location

Wilshire Oncology Medical Group

Corona, California, 92879, United States

Location

BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates

Orange, California, 92868, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Pasco Hernando Oncology Associates, PA

New Port Richey, Florida, 34652, United States

Location

Emory University - Winship Cancer Institute

Altanta, Georgia, 30322, United States

Location

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, 60007, United States

Location

Mary Bird Perkinds Cancer Center - Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 59169, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Case Comprehensive Cancer Center, University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Mercy Cancer Center

Toledo, Ohio, 43623, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Texas Oncology- Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Columbia Basin Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

ZNA Middelheim

Antwerp, Belgium

Location

University Hospital Antwerp

Edegem, Belgium

Location

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Juravinski Cancer Center

Hamilton, Ontario, L8V 5C2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Hopital Saint-André / Service d'Oncologie-Radiothérapie

Bordeaux, 33075, France

Location

Centre Antoine Lacassagne / Oncologie Médicale

Nice, 06189, France

Location

Institut Curie / Département d'Oncologie Médicale

Paris, 75248, France

Location

UKE Hamburg

Hamburg, Germany

Location

Attikon University Hospital

Athens, Greece

Location

Fovarosi Onkormanyzat Uzsoki Utcai Kórház

Budapest, Hungary

Location

Orszagos Onkologiai Intezet

Budapest, Hungary

Location

Pecsi Tudomanyegyetem

Pécs, Hungary

Location

Szegedi Tudományegyetem

Szegedi, Hungary

Location

Markusovszky Korhaz

Szombathely, Hungary

Location

Ufficio Sperimentazioni Cliniche c/o S.C. Oncologia Medica

Cuneo, Italy

Location

Fondazione IRCCS Istituto Nazionale del Tumori

Milan, Italy

Location

Ospedale San Paolo - Oncologia Medica

Milan, Italy

Location

University Hospital in Modena

Modena, Italy

Location

Centrum Onkologii - Instytyt im.M.Skłodowskiej-Curie

Krakow, Poland

Location

Wojewódzki Szpital Specjalistyczny im. M.Kopernika

Lodz, Poland

Location

Szpital MSWiA - Centrum Onkologi

Olsztyn, Poland

Location

Wielkopolskie Centrum Onkologii

Poznan, Poland

Location

State Health Care Institution "Arkhangelsk Regional Clinical Oncology Dispensary"

Arkhangelsk, Russia

Location

Regional State Health Care Institution "Belgorod Oncology Dispensary"

Belgorod, Russia

Location

State Health Care Institution "Chelyabinsk Regional Oncology Dispensary"

Chelyabinsk, Russia

Location

State Health Care Institution "Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan"

Kazan', Russia

Location

State Budgetary Health Care Institution "Clinical Oncology Dispensary #1" of Krasnodar Region Health Care Department

Krasnodar, Russia

Location

Regional Budgetary Health Care Institution "Kursk Regional Oncology Dispensary" of Health Care Committee of Kursk region

Kursk, Russia

Location

Federal State Budgetary Institution "Medical Research Radiology Center" of Ministry of Public Health and Social Development of Russian Federation, Obninsk

Obninsk, Russia

Location

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

Location

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

Location

St.Petersburg State Health Care Institution City Clinical Oncology Dispensary"

Saint Petersburg, Russia

Location

State Health Care Institution "Oncology Dispensary №2" of Krasnodar Region Health Care Department

Sochi, Russia

Location

State Health Care Institution "Tula Regional Oncology Dispensary"

Tula, Russia

Location

State Budgetary Healthcare Institution "Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan"

Ufa, Russia

Location

State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Oncological Hospital"

Yaroslavl, Russia

Location

Institute of Oncology Ljubljana

Ljubljana, Slovenia

Location

Hospital Vall D'Hebron

Barcelona, 08035, Spain

Location

Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Location

Hospital Santa Creu I Sant Pau

Barcelona, Spain

Location

Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol

Barcelona, Spain

Location

Hospital de Basurto

Bilbao, Spain

Location

Hospital de Navarra

Pamplona, Spain

Location

Beatson West of Scotland Cancer Center

Glasgow, G12 0YN, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7WG, United Kingdom

Location

St. James's University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Guy's and St. Thomas Hospital

London, SE1 9RT, United Kingdom

Location

The Royal Marsden Cancer Center, Fulham Road branch

London, SW3 6JJ, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Foundation Trust

Metropolitan Borough of Wirral, CH634JY, United Kingdom

Location

The Royal Marsden Cancer Center, Sutton Branch

Sutton, SM2 5PT, United Kingdom

Location

Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom

Location

The Velindre Hospital

Whitchurch, CF14 2TL, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma; Neoplasm Metastasis; Recurrence

Interventions

reolysin; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• James A Bonner, MD

  University of Alabama at Birmingham, Birmingham, AB, US

  PRINCIPAL INVESTIGATOR

• Kevin Harrington, MBBS MRCP FRCR

  The Royal Marsden Hospital, London, UK

  PRINCIPAL INVESTIGATOR

• Jan Vermorken, MD, PhD

  University Hospital, Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 21, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2014
• Last Updated: November 5, 2014

Record last verified: 2014-11

Locations

RU (14); GB (9); DE (1); GR (1); HU (5); BE (3); ES (7); FR (3); IT (4); PL (4); SL (1); US (21); CA (4)