Clinical trial NCT00843635
Conditions: Head and Neck Cancer
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
Sponsor: Donald T. Weed
Start date: 2008-09-01; Completion date: 2015-04-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity. arm 2: Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity. arm 3: Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents: