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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Donald T. Weed
• Treatments: Phosphodiesterase 5 Inhibitors; Tadalafil

Criteria

INCLUSION CRITERIA:

• Patients with surgically resectable oral cavity SCC, all subsites, T1 - T4, N0 - N3

• Patients with surgically resectable oropharyngeal SCC, all subsites, T1 - T2, N0 - N1

• Patients with surgically resectable T4 oropharyngeal SCC, all subsites, N0 - N3

• Patients must be 18 years old or older

EXCLUSION CRITERIA:

• Patients with previous surgical resection, radiation, or chemotherapy will be excluded to rule out possible effects of local tissue changes secondary to previous treatment

• Patients with surgically unresectable disease at primary site or regional lymph nodes

• Patients with T1 - T2 SCC oropharynx, N2 - N3

• Patients with T3 SCC oropharynx , N0 - N3

• Any patient for whom non-surgical therapy is recommended as treatment of choice after multidisciplinary treatment evaluation

• Patients with an altered mental status or not capacitated for their medical decision making

• Patients with severe or unstable cardiac or cerebrovascular disease are excluded

• myocardial infarction within the last 90 days

• unstable angina or angina occurring during sexual intercourse

• New York Heart Association Class 2 or greater heart failure in the last 6 months

• uncontrolled arrhythmias

• hypotension (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg)

• stroke within the last 6 months

• Left ventricle outflow obstruction.

• Pregnant and nursing mothers will not be enrolled given unknown effects to offspring

• Concurrent nitrate, alpha-blocker, or cytochrome P-450 inhibitor use

• Renal Insufficiency defined as creatinine clearance less than 51.

• Creatinine clearance will be determined by the following Cockcroft-Gault Equation:

(140-age) * (Wt in kg) * (0.85 if female) / (72 * Cr)

• Patients with hepatic insufficiency.

• Patients currently taking a Phosphodiesterase (PDE) inhibitors for erectile dysfunction

• Patients who are immunocompromised, for reasons not directly related to patients malignancy

• Patients with significant alcohol or drug abuse

• Patients with unilateral blindness, hereditary retinal disorders, or increased risk of blindness

• Patients with unilateral deafness, history of hearing loss, hearing aid dependence, or clinically evident hearing loss