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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall survival
every 3 months until death.
No
James A Bonner, MD
Principal Investigator
University of Alabama at Birmingham, Birmingham, AB, US
United States: Food and Drug Administration
REO 018
NCT01166542
June 2010
January 2013
Name | Location |
---|---|
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Arizona Oncology Associates | Tucson, Arizona 85712-2254 |
Wilshire Oncology Medical Group | Glendora, California 91741 |
Emory University - Winship Cancer Institute | Atlanta, Georgia 30322-1013 |
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21231 |
Pasco Hernando Oncology Associates, PA | New Port Richey, Florida 34642 |
Alexian Brothers Hospital Network | Elk Grove Village, Illinois 60007 |
Texas Oncology - Tyler | Tyler, Texas 75702 |
Cancer Therapy and Research Center at UTHSCSA | San Antonio, Texas 78229 |
Columbia Basin Hematology and Oncology | Kennewick, Washington 99336 |
Providence Health and Services | Burbank, California 91505 |
BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates | Orange, California 92868 |
Mary Bird Perkinds Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
Case Comprehensive Cancer Center, University Hospitals Case Medical Center | Cleveland, Ohio 44106 |
Mercy Cancer Center | Toledo, Ohio 43623 |
Texas Oncology- Sammons Cancer Center | Dallas, Texas 75246 |