At a glance
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Randomized, Placebo-Controlled, Phase 2 Study Of Induction Chemotherapy With Cisplatin/Carboplatin, And Docetaxel With Or Without Erlotinib In Patients With Head And Neck Squamous Cell Carcinomas Amenable For Surgical Resection
In Brief
A Phase 2 clinical trial evaluating Docetaxel, Erlotinib, and 4 other interventions for Head and Neck Cancer. Completed, enrolled 55 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
75 mg/m2 by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
150 mg by mouth daily continuously until the day before surgery.
150 mg by mouth daily continuously until the day before surgery.
Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery.
Phone call made to patient 1 time each year after the end of treatment visit.
Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.