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

Completed · Not applicable · Has a placebo group

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT00843635

Run by

Donald T. Weed

People needed

35

Starts

2008-09-01

Expected to finish

2015-04-01

Last updated by the study team

2015-10-19

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami Sylvester Comprehensive Cancer Center - Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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