(ChemotherapyAdvisor) – A treatment for head and neck cancer is now on its way into Phase 3 clinical trials. Oncolytics Biotech Inc. announced today that it has completed enrollment in the first stage of its Phase 3 clinical trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers (REO 018).
The comparative assessment of intravenous administration of REOLYSIN with the chemotherapy combination of paclitaxel and carboplatin versus the chemotherapy alone will take place in patients with metastatic or recurrent squamous cell carcinoma of the head and neck, or squamous cell cancer of the nasopharynx, who have progressed while (or after) receiving prior platinum-based chemotherapy.
In this randomized, two-arm, double-blind, multicenter, two-stage, adaptive trial, all patients will receive treatment every three weeks (21-day cycles) with paclitaxel and carboplatin, and will also receive, on a blinded basis, either intravenous placebo or intravenous REOLYSIN. All dosing takes place in the first five days of each cycle, with all patients receiving standard intravenous doses of paclitaxel and carboplatin on day one only, and on days one through five, either intravenous placebo or intravenous REOLYSIN.
The trial must meet the primary endpoint of overall survival (OS). The trial has just completed enrollment for the first, or non-adaptive, stage, which is designed to enroll 80 patients. The next stage will be adaptive and is designed to enroll between 100 and 400 patients.
The multicenter trial will be conducted at more than 80 centers in 12 countries in North America and Europe, including the U.S.