A Phase II Study of Vorinostat and Capecitabine in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) and Nasopharyngeal Carcinoma (NPC)
I. To determine the objective response rate (complete and partial) and duration of response
of the combination of vorinostat and capecitabine in patients with recurrent and/or
I. To evaluate the safety and tolerability of the combination of vorinostat and capecitabine
in patients with recurrent and/or metastatic SCCHN.
II. To determine the rate of progression-free survival (PFS) at 6 months. III. To determine
the rate and duration of stable disease (SD). IV. To determine the median PFS, and the rate
of PFS at 1 year. V. To determine the median overall survival (OS), and rates of overall
survival at 6 months and at 1 year.
OUTLINE: This is a multicenter, open-label study of patients with squamous cell carcinoma of
the head and neck followed by a randomized study of patients with nasopharyngeal carcinoma
Patients receive oral capecitabine twice daily and oral vorinostat once daily on days 1-14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients with complete response may receive two additional courses. Patients with NPC are
randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral capecitabine twice daily on days 1-14.
ARM II: Patients receive oral vorinostat once daily and capecitabine as in arm I on days
In both arms, courses repeat every 21 days in the absence of disease progression or
After completion of study therapy, patients will be followed up every 6 months for 1 year.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete and partial response) according to RECIST (Cohort A)
95% confidence intervals will be provided for all interesting results.
Up to 1 year
University Health Network-Princess Margaret Hospital
United States: Food and Drug Administration
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|Contra Costa Regional Medical Center||Martinez, California 94553-3156|
|Tower Cancer Research Foundation||Beverly Hills, California 90211|
|UC Davis Comprehensive Cancer Center||Sacramento, California 95817|
|University of Southern California||Los Angeles, California 90033|
|Penn State Milton S Hershey Medical Center||Hershey, Pennsylvania 17033|
|City of Hope Medical Group Inc||Pasadena, California 91105|
|Veterans Administration Hospital - Martinez||Martinez, California 94553|