Carcinoma, Squamous Cell of the Head and Neck Clinical Trial
Official title:
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.
The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN® therapeutic reovirus in combination with Paclitaxel and Carboplatin is effective and safe in the treatment of 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
active.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01166542 -
Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
|
Phase 3 | |
| Active, not recruiting |
NCT02573493 -
Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)
|
Phase 2 |