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Title   Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
Disease/Condition   Head and Neck Cancer
Description   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.

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. Overall survival is a primary endpoint of this trial.
Eligibility Criteria   To be eligible for this study, patients must meet several criteria, including but not limited to the following:

* Patient must be 18 years and older

* Patient has 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).

* Patient has life expectancy of at least 3 months.
Principal Investigator   Missak Haigentz, MD
Contact Name   Yoko Eng, RN
Phone   (718) 920-2090
Contact Email   yeng@montefiore.org
Post Date   07/13/2010
Protocol Number   10-09-290/West
Status   Recruiting
Current Trial Type   Interventional
Montefiore Clinical Trial   No
CHAM Clinical Trial   No