OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer

Phase 2 Active not recruiting 50 enrolled M.D. Anderson Cancer Center Genentech, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if giving the new drug, Tarceva® (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer. The safety of this treatment will also be studied.

Timeline

Start: 2004-01-28
Primary completion: 2025-05-01
Completion: 2026-06-30

Outcome

Met primary endpoint

paper The study met its primary endpoint and improved response rates compared with historical controls. PMID 29371473 ↗

Publications

William WN Jr, Tsao AS, Feng L, Ginsberg LE, Lee JJ, Kies MS, Glisson BS, Kim ES. Single Arm, Phase II Study of Cisplatin, Docetaxel, and Erlotinib in Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas. Oncologist. 2018 May;23(5):526-e49. doi: 10.1634/theoncologist.2017-0661. Epub 2018 Jan 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	60 mg/m2	Intravenous
Subject	Erlotinib	Small molecule	100 mg	Oral
Subject	Erlotinib	Small molecule	150 mg	Oral