N/A
N=35
Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00843635 ↗Enrolled (actual)
35
Serious AEs
8.6%
Results posted
Aug 2015
Primary outcome: Primary: Ratio of MDSC Concentration in the Blood — 0.7680; 0.7919; 0.9876 ratio from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tadalafil (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Donald T. Weed
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of MDSC Concentration in the Blood |
0.7680; 0.7919; 0.9876 | — |
| PRIMARY Ratio of T-reg Cell Concentration in the Blood |
0.7776; 0.6789; 0.8421 | — |
| PRIMARY Ratio of Tumor-specific T-cell Concentration in the Blood |
1.7401; 1.9020; 1.0933 | — |
| SECONDARY Optimal Dosing Schedule for Tadalafil |
— | — |
| SECONDARY Number of Participants Experiencing Adverse Events |
4; 10; 3 | — |
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.
Eligibility 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 ( 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
Data sourced from ClinicalTrials.gov (NCT00843635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.