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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

Phase 3
18 Years
Open (Enrolling)
Carcinoma, Squamous Cell of the Head and Neck

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Trial Information

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.

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

every 3 months until death.

Safety Issue:


Principal Investigator

James A Bonner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham, Birmingham, AB, US


United States: Food and Drug Administration

Study ID:

REO 018



Start Date:

June 2010

Completion Date:

January 2013

Related Keywords:

  • Carcinoma, Squamous Cell of the Head and Neck
  • carcinoma
  • squamous cell
  • head
  • neck
  • REOLYSIN (Reovirus Type 3 Dearing)
  • chemotherapy
  • Carboplatin
  • Paclitaxel
  • metastatic
  • recurrent
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



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