Study of Sorafenib/Cetuximab in Head and Neck Cancer
In this Phase I B/II trial, we seek to determine the safety and efficacy of sorafenib with standard dose cetuximab in the treatment of patients with Recurrent and /or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sorafenib and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN):a Phase I B/II Trial|
- Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]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.
- Overall Survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]To determine the overall survival for patients treated on protocol therapy.
|Study Start Date:||January 2008|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Cetuximab + sorafenib
Cetuximab will be given at standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib will be given at 200mg/m2 twice daily.
Sorafenib will be given 200 mg twice daily oral
Other Name: NexavarDrug: Cetuximab
Cetuximab will be given at standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly.
Other Name: Erbitux
This is a non-randomized phase I B/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.
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Neal Ready, MD||Duke University Health System|