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

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ClinicalTrials.gov Identifier: NCT00843635
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : August 13, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Donald T. Weed, University of Miami

Study Description
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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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Tadalafil Other: Placebo Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study of Phosphodiesterase-5 Inhibitor Tadalafil (Cialis) as an Immunomodulator in Patients With Oral Cavity and Oropharyngeal Squamous Cell Carcinoma.
Study Start Date : September 2008
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A - Tadalafil 10mg
Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
 Drug: Tadalafil
Given orally
Other Name: Cialis
Experimental: Arm B - Tadalafil 20mg
Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
 Drug: Tadalafil
Given orally
Other Name: Cialis
Placebo Comparator: Arm C - Placebo
Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
 Other: Placebo
Given orally


Outcome Measures
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Primary Outcome Measures :
  1. Ratio of MDSC Concentration in the Blood [ Time Frame: Baseline, End of Treatment at time of Surgery ]
    Ratio of the number of Myeloid Derived Suppressor Cells (MDSC) in the Blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.

  2. Ratio of T-reg Cell Concentration in the Blood [ Time Frame: Baseline, End of Treatment at Time of Surgery ]
    Ratio of the number of regulatory T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery..

  3. Ratio of Tumor-specific T-cell Concentration in the Blood [ Time Frame: Baseline, End of Treatment at Time of Surgery ]
    Ratio of the number of tumor specific T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.


Secondary Outcome Measures :
  1. Optimal Dosing Schedule for Tadalafil [ Time Frame: Baseline, End of Treatment at Time of Surgery. ]
  2. Number of Participants Experiencing Adverse Events [ Time Frame: From Day 1 to Day 20 ]
    Assessment of Treatment-related Side Effects. Number of participants experiencing adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843635


Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Donald T. Weed
Investigators
Principal Investigator: Donald T. Weed, MD University of Miami Sylvester Comprehensive Cancer Center
More Information
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Publications of Results:

Responsible Party: Donald T. Weed, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00843635     History of Changes
Other Study ID Numbers: 20070918
SCCC-2008006 ( Other Identifier: UM/Sylvester Comprehensive Cancer Center )
First Posted: February 13, 2009    Key Record Dates
Results First Posted: August 13, 2015
Last Update Posted: October 19, 2015
Last Verified: September 2015

Keywords provided by Donald T. Weed, University of Miami:
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
 Tadalafil
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents