Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx

Study Type: Interventional

Age/Sex Requirement: 18 years+ (None)

Sponsor: University of Miami Sylvester Comprehensive Cancer Center

Clinicaltrials.gov Identifier: NCT00843635

Purpose: To assess how well tadalafil works in treating patients who are undergoing surgery for cancer of the oral cavity or oropharynx. The primary outcome measure is immune response as assessed by the number of CD4+ and CD8+ cells in tumor tissue by immunohistochemistry and proliferation of CD8+ lymphocytes in peripheral blood mononuclear cells by fluorescence activated cell sorting. Secondary outcomes measures include optimal dosing schedule for tadalafil, treatment-related side effects, progression-free survival, and overall survival.

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