Trial Outcomes & Findings for Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx (NCT NCT00843635)
NCT ID: NCT00843635
Last Updated: 2015-10-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Baseline, End of Treatment at time of Surgery
Results posted on
2015-10-19
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
5
|
|
Overall Study
COMPLETED
|
13
|
13
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
0
|
Baseline Characteristics
Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx
Baseline characteristics by cohort
| Measure |
Arm A - Tadalafil 10mg
n=15 Participants
Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
Arm B - Tadalafil 20mg
n=15 Participants
Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
Arm C - Placebo
n=5 Participants
Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
54 years
n=7 Participants
|
67 years
n=5 Participants
|
63 years
n=4 Participants
|
|
Age, Customized
< 50 years of age
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
0 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Age, Customized
50 to 59 years of age
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Age, Customized
60 to 69 years of age
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Age, Customized
70+ years of age
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
5 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Alcohol Use
Never
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Alcohol Use
Current Use
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
4 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Alcohol Use
Past Use
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Tobacco Use
Current
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
0 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Tobacco Use
Quit < 20 years ago
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Tobacco Use
Quit > 20 years ago
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Tobacco Use
Never
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Type of Tobacco Use
Never
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Type of Tobacco Use
Cigarettes
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
4 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Type of Tobacco Use
Cigar/Pipe
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Type of Tobacco Use
Snuff/Chew/Smokeless
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Site
Oral Cavity
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
4 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Site
Oro Pharynx
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Tumor size (cm) Mean
|
3.7 cm
STANDARD_DEVIATION 1.8 • n=5 Participants
|
2.4 cm
STANDARD_DEVIATION 1.3 • n=7 Participants
|
3.5 cm
STANDARD_DEVIATION 1.9 • n=5 Participants
|
3.1 cm
STANDARD_DEVIATION 1.7 • n=4 Participants
|
|
Tumor Size (cm) Median
|
3 cm
n=5 Participants
|
2.1 cm
n=7 Participants
|
4 cm
n=5 Participants
|
3 cm
n=4 Participants
|
|
T-Stage
T1
|
1 participants
n=5 Participants
|
7 participants
n=7 Participants
|
1 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
T-Stage
T2
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
T-Stage
T3
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
T-Stage
T4
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
N Stage - Regional Lymph Nodes
N0
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
N Stage - Regional Lymph Nodes
N1
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
N Stage - Regional Lymph Nodes
N2b
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
N Stage - Regional Lymph Nodes
N2c
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
N Stage - Regional Lymph Nodes
N3
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Positive for Human Papillomavirus (HPV+)
Yes
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Positive for Human Papillomavirus (HPV+)
No
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
5 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Pre-Operative Treatment
No
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
3 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Pre-Operative Treatment
Yes
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Pre-Operative Treatment, Details
No
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
3 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Pre-Operative Treatment, Details
Chemo + Radiation
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Pre-Operative Treatment, Details
Radiation only
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment at time of SurgeryRatio 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.
Outcome measures
| Measure |
Arm C - Placebo
n=5 Participants
Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally
|
Arm A - Tadalafil 10mg
n=13 Participants
Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
Arm B - Tadalafil 20mg
n=13 Participants
Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
|---|---|---|---|
|
Ratio of MDSC Concentration in the Blood
|
0.9876 ratio from baseline
Interval 0.8478 to 1.026
|
0.7680 ratio from baseline
Interval 0.644 to 1.01
|
0.7919 ratio from baseline
Interval 0.4344 to 1.115
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment at Time of SurgeryRatio of the number of regulatory T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery..
Outcome measures
| Measure |
Arm C - Placebo
n=5 Participants
Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally
|
Arm A - Tadalafil 10mg
n=13 Participants
Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
Arm B - Tadalafil 20mg
n=13 Participants
Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
|---|---|---|---|
|
Ratio of T-reg Cell Concentration in the Blood
|
0.8421 ratio from baseline
Interval 0.5255 to 0.9142
|
0.7776 ratio from baseline
Interval 0.5751 to 0.8869
|
0.6789 ratio from baseline
Interval 0.5234 to 1.033
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment at Time of SurgeryPopulation: Data for 31 patients were analyzed.
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.
Outcome measures
| Measure |
Arm C - Placebo
n=3 Participants
Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally
|
Arm A - Tadalafil 10mg
n=12 Participants
Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
Arm B - Tadalafil 20mg
n=10 Participants
Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
|---|---|---|---|
|
Ratio of Tumor-specific T-cell Concentration in the Blood
|
1.0933 ratio from baseline
Interval 0.7884 to 1.2466
|
1.7401 ratio from baseline
Interval 1.1478 to 2.7495
|
1.9020 ratio from baseline
Interval 1.0413 to 6.1008
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment at Time of Surgery.Population: Optimal dosing schedule of Tadalafil not determined due to no proven superiority of one dosing arm over the other.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 to Day 20Assessment of Treatment-related Side Effects. Number of participants experiencing adverse events
Outcome measures
| Measure |
Arm C - Placebo
n=5 Participants
Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally
|
Arm A - Tadalafil 10mg
n=15 Participants
Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
Arm B - Tadalafil 20mg
n=15 Participants
Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
|---|---|---|---|
|
Number of Participants Experiencing Adverse Events
|
3 participants
|
4 participants
|
10 participants
|
Adverse Events
Arm A - Tadalafil 10mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm B - Tadalafil 20mg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm C - Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - Tadalafil 10mg
n=15 participants at risk
Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
Arm B - Tadalafil 20mg
n=15 participants at risk
Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
Arm C - Placebo
n=5 participants at risk
Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain - Grade 3
|
6.7%
1/15 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Myalgia - Grade 3
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
Other adverse events
| Measure |
Arm A - Tadalafil 10mg
n=15 participants at risk
Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
Arm B - Tadalafil 20mg
n=15 participants at risk
Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Tadalafil: Given orally
|
Arm C - Placebo
n=5 participants at risk
Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Placebo: Given orally
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain - Grade 2
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
|
General disorders
Headache - Grade 2
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
|
General disorders
Neck Pain - Grade 2
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
|
General disorders
Pain in Extremity - Grade 2
|
0.00%
0/15
|
6.7%
1/15 • Number of events 2
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Back Pain - Grade 1
|
0.00%
0/15
|
6.7%
1/15 • Number of events 2
|
0.00%
0/5
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Cough - Grade 1
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Diarrhea - Grade 1
|
6.7%
1/15 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
|
Ear and labyrinth disorders
Ear Nose Throat Examination abnormal
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
0.00%
0/5
|
|
General disorders
Headache - Grade 1
|
0.00%
0/15
|
6.7%
1/15 • Number of events 2
|
40.0%
2/5 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck Pain - Grade 1
|
0.00%
0/15
|
6.7%
1/15 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Pain in Extremity - Grade 1
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Grade 1
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Reproductive system and breast disorders
Sexual - Grade 1
|
0.00%
0/15
|
0.00%
0/15
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place