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
|
|---|---|---|---|---|
|
Pre-Operative Treatment, Details
Chemo + Radiation
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Pre-Operative Treatment, Details
Radiation only
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Age, Continuous
|
61 years
n=99 Participants
|
54 years
n=107 Participants
|
67 years
n=206 Participants
|
63 years
n=7 Participants
|
|
Age, Customized
< 50 years of age
|
2 participants
n=99 Participants
|
6 participants
n=107 Participants
|
0 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Age, Customized
50 to 59 years of age
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Age, Customized
60 to 69 years of age
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
12 participants
n=7 Participants
|
|
Age, Customized
70+ years of age
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
1 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
12 participants
n=99 Participants
|
8 participants
n=107 Participants
|
3 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
2 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
5 participants
n=206 Participants
|
35 participants
n=7 Participants
|
|
Alcohol Use
Never
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Alcohol Use
Current Use
|
11 participants
n=99 Participants
|
8 participants
n=107 Participants
|
4 participants
n=206 Participants
|
23 participants
n=7 Participants
|
|
Alcohol Use
Past Use
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
0 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Tobacco Use
Current
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
0 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Tobacco Use
Quit < 20 years ago
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Tobacco Use
Quit > 20 years ago
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
0 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Tobacco Use
Never
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Type of Tobacco Use
Never
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Type of Tobacco Use
Cigarettes
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
4 participants
n=206 Participants
|
27 participants
n=7 Participants
|
|
Type of Tobacco Use
Cigar/Pipe
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Type of Tobacco Use
Snuff/Chew/Smokeless
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Site
Oral Cavity
|
13 participants
n=99 Participants
|
14 participants
n=107 Participants
|
4 participants
n=206 Participants
|
31 participants
n=7 Participants
|
|
Site
Oro Pharynx
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Tumor size (cm) Mean
|
3.7 cm
STANDARD_DEVIATION 1.8 • n=99 Participants
|
2.4 cm
STANDARD_DEVIATION 1.3 • n=107 Participants
|
3.5 cm
STANDARD_DEVIATION 1.9 • n=206 Participants
|
3.1 cm
STANDARD_DEVIATION 1.7 • n=7 Participants
|
|
Tumor Size (cm) Median
|
3 cm
n=99 Participants
|
2.1 cm
n=107 Participants
|
4 cm
n=206 Participants
|
3 cm
n=7 Participants
|
|
T-Stage
T1
|
1 participants
n=99 Participants
|
7 participants
n=107 Participants
|
1 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
T-Stage
T2
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
2 participants
n=206 Participants
|
15 participants
n=7 Participants
|
|
T-Stage
T3
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
T-Stage
T4
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
1 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
N Stage - Regional Lymph Nodes
N0
|
7 participants
n=99 Participants
|
9 participants
n=107 Participants
|
4 participants
n=206 Participants
|
20 participants
n=7 Participants
|
|
N Stage - Regional Lymph Nodes
N1
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
N Stage - Regional Lymph Nodes
N2b
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
0 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
N Stage - Regional Lymph Nodes
N2c
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
N Stage - Regional Lymph Nodes
N3
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Positive for Human Papillomavirus (HPV+)
Yes
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Positive for Human Papillomavirus (HPV+)
No
|
12 participants
n=99 Participants
|
14 participants
n=107 Participants
|
5 participants
n=206 Participants
|
31 participants
n=7 Participants
|
|
Pre-Operative Treatment
No
|
10 participants
n=99 Participants
|
13 participants
n=107 Participants
|
3 participants
n=206 Participants
|
26 participants
n=7 Participants
|
|
Pre-Operative Treatment
Yes
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Pre-Operative Treatment, Details
No
|
10 participants
n=99 Participants
|
13 participants
n=107 Participants
|
3 participants
n=206 Participants
|
26 participants
n=7 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 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
|
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
|
|---|---|---|---|
|
Ratio of MDSC Concentration in the Blood
|
0.7680 ratio from baseline
Interval 0.644 to 1.01
|
0.7919 ratio from baseline
Interval 0.4344 to 1.115
|
0.9876 ratio from baseline
Interval 0.8478 to 1.026
|
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 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
|
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
|
|---|---|---|---|
|
Ratio of T-reg Cell Concentration in the Blood
|
0.7776 ratio from baseline
Interval 0.5751 to 0.8869
|
0.6789 ratio from baseline
Interval 0.5234 to 1.033
|
0.8421 ratio from baseline
Interval 0.5255 to 0.9142
|
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 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
|
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
|
|---|---|---|---|
|
Ratio of Tumor-specific T-cell Concentration in the Blood
|
1.7401 ratio from baseline
Interval 1.1478 to 2.7495
|
1.9020 ratio from baseline
Interval 1.0413 to 6.1008
|
1.0933 ratio from baseline
Interval 0.7884 to 1.2466
|
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 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
|
|---|---|---|---|
|
Number of Participants Experiencing Adverse Events
|
4 participants
|
10 participants
|
3 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