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Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers

NCT01166542 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2014-11-05

No results posted yet for this study

Summary

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.

Conditions

  • Carcinoma, Squamous Cell of the Head and Neck

Interventions

BIOLOGICAL

REOLYSIN

3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle

DRUG

Carboplatin

5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle

DRUG

Paclitaxel

175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • James A Bonner, MD · University of Alabama at Birmingham, Birmingham, AB, US

  • Kevin Harrington, MBBS MRCP FRCR · The Royal Marsden Hospital, London, UK

  • Jan Vermorken, MD, PhD · University Hospital, Antwerp, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-04-30
Completion
2014-05-31

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Poland
  • Russia
  • Slovenia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01166542 on ClinicalTrials.gov