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)
PRIMARY OBJECTIVES:
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
metastatic SCCHN.
SECONDARY OBJECTIVES:
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
(NPC).
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
1-14.
In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study therapy, patients will be followed up every 6 months for 1 year.
Interventional
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
No
Eric Chen
Principal Investigator
University Health Network-Princess Margaret Hospital
United States: Food and Drug Administration
NCI-2011-02556
NCT01267240
December 2010
Name | Location |
---|---|
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 |