Status:
COMPLETED
Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx
Lead Sponsor:
Donald T. Weed
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
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 t...
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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00843635
Start Date
September 1 2008
End Date
April 1 2015
Last Update
October 19 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136