Phase 2 Study of Intravenous Administration of a Wild-Type Reovirus (REOLYSIN®) in Combination With Paclitaxel and Carboplatin in Patients With Platinum-Refractory Metastatic and/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. 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 recently 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 6-9 months.
Preliminary assessment of a Phase 1 study being 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
This Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN® given
intravenously in combination with paclitaxel and carboplatin every 3 weeks in patients with
squamous cell carcinoma of the head and neck.
Response is a primary endpoint of this trial. Patients will be clinically evaluated after
each course of treatment and radiologically every other cycle. A complete or partial
response must be confirmed at least 4 weeks after the first assessment that documents such a
response and every two cycles thereafter.
The safety of the paclitaxel, carboplatin and REOLYSIN® combination will be assessed by the
evaluation of the type, frequency and severity of adverse events, changes in clinical
laboratory tests, immunogenicity and physical examination.
Patients may continue to receive therapy under this protocol, provided they have not
experienced either progressive disease or unacceptable drug-related toxicity that does not
respond to either supportive care or dose reduction.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population
For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met.
Monica Mita, MD
Cancer Therapy and Research Center at UTHSCSA
United States: Food and Drug Administration
|Montefiore Medical Center||Bronx, New York 10467-2490|
|Cancer Therapy and Research Center at UTHSCSA||San Antonio, Texas 78229|