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

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.