Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Biological therapies, such as tadalafil, may stimulate the immune system in
      different ways and stop tumor cells from growing.

      PURPOSE: This randomized clinical trial is studying how well tadalafil works in treating
      patients who are undergoing surgery for cancer of the oral cavity or oropharynx.
    

Detailed description: 
      OBJECTIVES:

        -  To analyze the phenotype and the function of the tumor-induced suppressive network
           associated with squamous cell carcinoma (SCC) of the head and neck in patients with SCC
           of the oral cavity or oropharynx treated with tadalafil followed by definitive surgical
           resection.

        -  To analyze the immune response before and after treatment with tadalafil to determine
           whether or not tadalafil treatment modulates in these patients.

        -  To compare two doses of tadalafil to determine whether there are measurable differences
           in immune response in these patients.

        -  To analyze treatment-related side effects of tadalafil at each of the two doses tested
           in these patients.

      OUTLINE: Patients are randomized to 1 of 3 treatment arms.

        -  Arm I: Patients receive oral tadalafil once daily on days 1-20 in the absence of
           unacceptable toxicity.

        -  Arm II: Patients receive oral tadalafil (at a higher dose than in arm I) once daily on
           days 1-20 in the absence of unacceptable toxicity.

        -  Arm III: Patients receive oral placebo once daily on days 1-20 in the absence of
           unacceptable toxicity.

      All patients undergo scheduled definitive surgical resection on day 23.

      Patients undergo blood sample collection at baseline, on day 20, and at 6 weeks after
      surgical resection for correlative laboratory studies. Patients also undergo tumor tissue
      sample collection at baseline and at the time of surgical resection. Samples are analyzed for
      immunological markers by Fluorescence-activated cell sorting (FACS) and Immunohistochemistry
      (IHC).

      After completion of study treatment, patients are followed periodically for at least 3 years.
    

Intervention name(s): Tadalafil; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Given orally; Given orally
Other intervention name(s): Cialis
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: stage I squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage I verrucous carcinoma of the oral cavity; stage II verrucous carcinoma of the oral cavity; stage III verrucous carcinoma of the oral cavity; stage IV verrucous carcinoma of the oral cavity