Recurrent Laryngeal Squamous Cell Carcinoma Clinical Trial
Official title:
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)
This partially randomized phase II trial studies giving capecitabine and vorinostat in treating patients with head and neck cancer that has come back after previous treatment or that has spread to other areas in the body. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine together with vorinostat is more effective than capecitabine alone in treating patients with cancer of the head and neck cancer.
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 squamous cell carcinoma of the head and neck (SCCHN). (SCCHN) II. 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
nasopharyngeal carcinoma (NPC). (NPC)
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of the combination of vorinostat and capecitabine
in patients with recurrent and/or metastatic SCCHN. (SCCHN) II. To determine the rate of
progression-free survival (PFS) at 6 months. (SCCHN) III. To determine the rate and duration
of stable disease (SD). (SCCHN) IV. To determine the median PFS, and the rate of PFS at 1
year. (SCCHN) V. To determine the median overall survival (OS), and rates of overall
survival at 6 months and at 1 year. (SCCHN) VI. To evaluate the safety and tolerability of
the combination of vorinostat and capecitabine in patients with recurrent and/or metastatic
NPC. (NPC) VII. To determine the duration of objective response. (NPC) VIII. To determine
the rate and duration of stable disease (SD). (NPC) IX. To determine the median PFS, and the
rate of PFS at 1 year. (NPC) X. To determine the median overall survival (OS), and rates of
overall survival at 6 months and at 1 year. (NPC)
OUTLINE: This is a non-randomized, open-label study of patients with SCCHN and NPC (Stage
I), followed by a randomized study of patients with NPC (Stage II).
STAGE I: Patients receive capecitabine orally (PO) twice daily (BID) and vorinostat PO daily
on days 1-14. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
STAGE II: Patients with NPC are randomized to 1 of 2 treatment arms.
ARM I: Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive capecitabine PO BID on days 1-14. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients will be followed up at 3-4 weeks and then
every 6 months for 1 year.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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