Sorafenib and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN):a Phase IB/II Trial
This is a non-randomized phase IB/II trial enrolling 43 patients with recurrent and/or
metastatic SCCHN who are not candidates for surgical salvage or definitive radiation.
Subjects will receive Cetuximab and sorafenib until disease progression. Cetuximab will be
given at standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly.
Sorafenib will be given 200 mg twice daily oral, continuous dosing to the 6 patients in
cohort 1. If less than 3 patients experience dose limiting toxicities (DLT) at the 200mg BID
dose, then 6 patients will be accrued at the 400mg BID dose level and toxicities will again
be examined. Sorafenib will be given 400 mg twice daily oral, continuous dosing to the
patients in cohort 2. One cycle equals 28 days. Tumor assessment will be performed every 8
weeks. Treatment continues until disease progression or unacceptable side effects.
Participating subjects will be asked to take part in an optional correlative study to
provide previously archived diagnostic or therapeutic tumor samples obtained during the
course of their routine medical care for their cancer of the head/neck. The optional tissue
repository project is Duke University Health System (DUHS) Institutional Review Board (IRB)
approved (eIRB # 11138 / "Tissue Acquisition Protocol for Analysis of Effects of Novel
Chemotherapeutic Compounds). Subjects will be asked to sign a separate consent form to
participate in the tissue collection study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase IB: To evaluate the safety of protocol therapy by examining cycle 1 dose limiting toxicities in patients receiving 50% reduced protocol therapy and protocol therapy.
Neal Ready, MD
Duke University Health System
United States: Institutional Review Board
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