Trial to Determine the CR Rate at the Primary Tumor Site After 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head & Neck Carcinoma Treated With Definitive Concurrent Cisplatin & Radiation Therapy
To determine the clinical CR rate (CR-p) at the primary tumor site to an IC regimen of
weekly Abraxane and cetuximab with CF (ACCF) given for two cycles (over 6 weeks) in patients
with locally advanced non-metastatic HNSCC. The assessment of primary tumor site response
will be performed by the treating physician by careful clinical examination using WHO
criteria. Radiographic studies will also be performed to assess primary tumor site response
but will be used primarily to confirm lack of disease progression that may not be detected
based on clinical examination alone.
The secondary objectives include:
- Document the clinical PR rate (PR-p) at the primary tumor site with this IC regimen
- Document the clinical CR and PR rates at the involved regional nodes (CR-n and PR-n)
with this IC regimen
- Document the clinical overall CR rate (CR-o) (defined as achievement of a CR at the
primary tumor site and at the involved regional nodes) and the clinical overall PR rate
(PR-o) with this IC regimen
- Document the CR (CR-p, CR-n, and CR-o) and PR (PR-p, PR-n, and PR-o) rates by FDG
uptake on PET scan after this IC regimen
- Document radiographic CR (CR-p, CR-n, and CR-o) and PR (PR-p, PR-n, and PR-o) rates as
assessed by conventional CT scan using RECIST criteria after this IC regimen.
- Correlate primary tumor site, nodal and overall tumor response rates based on WHO
criteria of assessment with that based on CT scan and FDG-PET/CT.
- Document and quantify SPARC expression by IHC in primary tumor tissue obtained at
baseline in each patient and attempt to correlate these results with primary tumor site
response to ACCF.
- Document and grade AE's with this IC regimen with a pre-planned safety analysis after
the first ten patients have completed the IC regimen.
- Determine the overall survival (OS), disease-free survival (DFS), and progression-free
survival (PFS) of this patient population.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the clinical complete response to the primary tumor
Douglas Adkins, M.D.
United States: Food and Drug Administration
08-0911 / 201105504
|Washington University||St. Louis, Missouri 63110|