Carcinoma, Squamous Cell of the Head and Neck Clinical Trial
Official title:
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
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. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00753038 -
Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck Carcinoma
|
Phase 2 | |
| 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 |