Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 2 Completed 101 enrolled Cliniques universitaires Saint-Luc- Université Catholique de Louvain

RandomizedParallel-groupOpen-labelTreatment

Summary

In this clinical trial, the investigators want to know if cabazitaxel is more effective than methotrexate for patients with recurrent or metastatic squamous cell carcinoma of the head and neck in palliative treatment.

Timeline

Start: 2012-02
Primary completion: 2014-11
Completion: 2014-11

Outcome

Missed primary endpoint

paper This phase II study did not meet its primary endpoint. PMID 27903924 ↗

Publications

Machiels JP, Van Maanen A, Vandenbulcke JM, Filleul B, Seront E, Henry S, D'Hondt L, Lonchay C, Holbrechts S, Boegner P, Brohee D, Dequanter D, Louviaux I, Sautois B, Whenham N, Berchem G, Vanderschueren B, Fontaine C, Schmitz S, Gillain A, Schoonjans J, Rottey S. Randomized Phase II Study of Cabazitaxel Versus Methotrexate in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-Based Therapy. Oncologist. 2016 Dec;21(12):1416-e17. doi: 10.1634/theoncologist.2016-0296. Epub 2016 Nov 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cabazitaxel	Other / unclassified	25 mg/m2	Intravenous
Comparator	Methotrexate	Small molecule	50 mg/m2	Intravenous