Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection
Summary
The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied. In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Timeline
- Start
- 2013-12-16
- Primary completion
- 2025-01-06
- Completion
- 2025-01-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |