Stage III Squamous Cell Carcinoma of the Oropharynx Clinical Trial
Official title:
A Phase I Trial Of Vorinostat In The Treatment Of Advanced Laryngeal, Hypopharyngeal, Nasopharyngeal And Oropharyngeal Squamous Cell Carcinoma Of The Head And Neck.
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill
tumor cells. Giving vorinostat together with chemotherapy and radiation therapy may kill more
tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when
given together with cisplatin and radiation therapy in treating patients with stage III or
stage IVa squamous cell cancer of the oropharynx which is either unresectable or borderline
resectable.
PRIMARY OBJECTIVES:
I. To determine the maximally tolerated dose of Vorinostat in combination with concurrent
chemoradiotherapy for the treatment of advance stage OPSCC.
SECONDARY OBJECTIVES:
l. To determine the complete response rate, overall survival and progression free survival
using the maximally tolerated dose of Vorinostat.
TERTIARY OBJECTIVES:
I. To assess treatment related acute and late toxicities when combining Vorinostat with
chemoradiation and correlate these toxicities to molecular markers of apoptosis in tumor and
normal oral mucosa.
II. To evaluate the effect of Vorinostat on tumor immune surveillance, particularly in HPV
positive patients.
III. To illustrate that Vorinostat alters the methylation status of commonly methylated genes
in OPSCC.
OUTLINE: This is a dose-escalation study of vorinostat. Patients receive oral vorinostat on
days 0-2 and cisplatin IV on days 7, 21, and 35. Patients undergo radiotherapy 5 days a week
beginning on day 7. Patients also receive concurrent oral vorinostat along with the
radiotherapy to be given 3 days per week (Monday, Tuesday, and Wednesday). Treatment
continues for 7 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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