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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Donald T. Weed, University of Miami
ClinicalTrials.gov Identifier:
NCT00843635
First received: February 12, 2009
Last updated: August 7, 2015
Last verified: August 2015
Results First Received: June 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Drug: Tadalafil
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A - Tadalafil 10mg

Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.

Tadalafil: Given orally

Arm B - Tadalafil 20mg

Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.

Tadalafil: Given orally

Arm C - Placebo

Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.

Placebo: Given orally


Participant Flow:   Overall Study
    Arm A - Tadalafil 10mg     Arm B - Tadalafil 20mg     Arm C - Placebo  
STARTED     15     15     5  
COMPLETED     13     13     5  
NOT COMPLETED     2     2     0  
Adverse Event                 2                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Race/ethnicity reported for 34 of the 35 participants, specifically for 14 of the 15 participants in Arm B - Tadalafil 20mg.

Reporting Groups
  Description
Arm A - Tadalafil 10mg

Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.

Tadalafil: Given orally

Arm B - Tadalafil 20mg

Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.

Tadalafil: Given orally

Arm C - Placebo

Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.

Placebo: Given orally

Total Total of all reporting groups

Baseline Measures
    Arm A - Tadalafil 10mg     Arm B - Tadalafil 20mg     Arm C - Placebo     Total  
Number of Participants  
[units: participants]
  15     15     5     35  
Age  
[units: years]
Mean (Standard Deviation)
  59.3  (10.5)     59  (13.9)     66.8  (4.3)     60.3  (11.6)  
Age  
[units: years]
Median (Inter-Quartile Range)
  61   (39 to 76)     54   (39 to 81)     67   (60 to 72)     63   (39 to 81)  
Age, Customized  
[units: participants]
       
< 50 years of age     2     6     0     8  
50 to 59 years of age     5     2     0     7  
60 to 69 years of age     5     3     4     12  
70+ years of age     3     4     1     8  
Gender  
[units: participants]
       
Female     3     4     1     8  
Male     12     11     4     27  
Race/Ethnicity, Customized  
[units: participants]
       
White, Non-Hispanic     12     8     3     23  
Hispanic     3     5     2     10  
South Asian     0     1     0     1  
Not Reported     0     1     0     1  
Region of Enrollment  
[units: participants]
       
United States     15     15     5     35  
Alcohol Use  
[units: participants]
       
Never     2     2     1     5  
Current Use     11     8     4     23  
Past Use     2     5     0     7  
Tobacco Use  
[units: participants]
       
Current     9     9     0     18  
Quit < 20 years ago     3     1     4     8  
Quit > 20 years ago     0     3     0     3  
Never     3     2     1     6  
Type of Tobacco Use  
[units: participants]
       
Never     3     2     1     6  
Cigarettes     12     11     4     27  
Cigar/Pipe     0     1     0     1  
Snuff/Chew/Smokeless     0     1     0     1  
Site  
[units: participants]
       
Oral Cavity     13     14     4     31  
Oro Pharynx     2     1     1     4  
Tumor size (cm) Mean  
[units: cm]
Mean (Standard Deviation)
  3.7  (1.8)     2.4  (1.3)     3.5  (1.9)     3.1  (1.7)  
Tumor Size (cm) Median  
[units: cm]
Median (Inter-Quartile Range)
  3   (2 to 8.5)     2.1   (0.5 to 5.5)     4   (0.6 to 5.5)     3   (0.5 to 8.5)  
T-Stage [1]
[units: participants]
       
T1     1     7     1     9  
T2     9     4     2     15  
T3     1     0     1     2  
T4     4     4     1     9  
N Stage - Regional Lymph Nodes [2]
[units: participants]
       
N0     7     9     4     20  
N1     2     1     1     4  
N2b     4     3     0     7  
N2c     1     2     0     3  
N3     1     0     0     1  
Positive for Human Papillomavirus (HPV+)  
[units: participants]
       
Yes     3     1     0     4  
No     12     14     5     31  
Pre-Operative Treatment  
[units: participants]
       
No     10     13     3     26  
Yes     5     2     2     9  
Pre-Operative Treatment, Details  
[units: participants]
       
No     10     13     3     26  
Chemo + Radiation     1     1     2     4  
Radiation only     4     1     0     5  
[1]

Number of participants on each arm grouped by the size and/or extent (reach) of the primary tumor (T) at Baseline: T1, T2, T3 and T4.

Numbers after the T (such as T1, T2, T3, and T4) might describe the tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues.

[2]

Number of participants on each arm grouped by whether or not the cancer has reached nearby lymph nodes at Baseline:

  • N0 - No regional lymph node involvement (no cancer found in the lymph nodes)
  • N1 - N3 - Involvement of regional lymph nodes (number and/or extent of spread)



  Outcome Measures
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1.  Primary:   Ratio of MDSC Concentration in the Blood   [ Time Frame: Baseline, End of Treatment at time of Surgery ]

2.  Primary:   Ratio of T-reg Cell Concentration in the Blood   [ Time Frame: Baseline, End of Treatment at Time of Surgery ]

3.  Primary:   Ratio of Tumor-specific T-cell Concentration in the Blood   [ Time Frame: Baseline, End of Treatment at Time of Surgery ]

4.  Secondary:   Optimal Dosing Schedule for Tadalafil   [ Time Frame: Baseline, End of Treatment at Time of Surgery. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Number of Participants Experiencing Adverse Events   [ Time Frame: From Day 5 to Day 20 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Race/Ethnicity baseline characteristics reported for 34 of 35 patients enrolled. Data analyzed for outcome measure for the 31 participants who completed the study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Donald T. Weed MD FACS
Organization: University of Miami
phone: 305-243-9095
e-mail: dweed@miami.edu


Publications of Results:

Responsible Party: Donald T. Weed, University of Miami
ClinicalTrials.gov Identifier: NCT00843635     History of Changes
Other Study ID Numbers: 20070918, SCCC-2008006
Study First Received: February 12, 2009
Results First Received: June 3, 2015
Last Updated: August 7, 2015
Health Authority: United States: Food and Drug Administration