Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab in Patients With Refractory, Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
PRIMARY OBJECTIVES:
I. Compare the progression free survival (PFS) of the combination of cetuximab and sorafenib
to that of cetuximab alone in patients with recurrent, refractory or metastatic squamous
cell carcinoma of the head and neck (SCCHN).
SECONDARY OBJECTIVES:
I. To evaluate the response rate, overall survival (OS) and toxicity of the combination of
cetuximab and sorafenib and of cetuximab alone.
II. To evaluate the presence of EGFRvIII mutation, increased EGFR gene copy number and
activated EGFR gene expression signature, and correlate with clinical parameters (RR, OS and
PFS) in the cetuximab alone and cetuximab/sorafenib arms.
III. To evaluate whether VEGF receptor family and their ligand expression can predict
response to cetuximab/sorafenib.
IV. To determine the proteomic profiles in serum and tumors that can predict the response
and survival upon the treatment with cetuximab or cetuximab/sorafenib.
V. To evaluate the effect of therapy on both general and head and neck specific
functionality, symptom burden and QOL.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral
placebo twice daily on days 1-21. (oral placebo closed as of 02/18/2010).
ARM II: Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral
sorafenib tosylate twice daily on days 1-21.
In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
Paraffin embedded tissue samples are collected at baseline for pharmacogenomic studies and
blood samples are collected at baseline and for the first 3 courses for research purposes.
Quality of life and symptom burden are assessed by Vanderbilt Head and Neck Symptom Survey,
FACT-HN, and Fatigue and Pain Inventory questionnaires at baseline, at day 43, and at 3 and
6 months.
After completion of study treatment, patients are followed periodically for 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival (PFS)
Will be summarized with the Kaplan-Meier curve by arm. Confidence intervals for the median and survival rates at different time points will be constructed when appropriate.
From study entry to disease progression or death, whichever is earlier, assessed up to 3 years
No
Jill Gilbert
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
NCI-2012-02847
NCT00939627
July 2009
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |