Trial Outcomes & Findings for Efficacy of Doxycycline on Metakaryote Cell Death in Patients With Resectable Pancreatic Cancer (NCT NCT02775695)
NCT ID: NCT02775695
Last Updated: 2023-07-03
Results Overview
The histopathologic response of the primary tumor will be assessed using the College of American Pathology criteria for residual tumor response following neoadjuvant therapy for the exocrine pancreas. Researchers will enumerate the number of observed dead/dying metakaryotes per 1 gram of resected pancreatic tissue.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Month 3 visit
Results posted on
2023-07-03
Participant Flow
Fifteen subjects were consented to participate in the study. Three did not meet eligibility criteria during screening.
Participant milestones
| Measure |
Doxycycline Administered to Patients
Patients will receive oral doxycycline and trough serum concentrations for pharmacokinetic studies will be obtained.
Doxycycline: Treatment with doxycycline hyclate will be administered as an oral agent on an outpatient basis. Patients will receive doxycycline 100 mg twice daily for a period of 8 weeks (56 days). Upon registration (baseline) and at the first, third, and fifth days of doxycycline therapy, patients will be seen to obtain trough serum concentrations for pharmacokinetic studies. Additional serum levels will be checked on days 8, 15, 22 and 29.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Doxycycline on Metakaryote Cell Death in Patients With Resectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Doxycycline Administered to Patients
n=12 Participants
Patients will receive oral doxycycline and trough serum concentrations for pharmacokinetic studies will be obtained.
Doxycycline: Treatment with doxycycline hyclate will be administered as an oral agent on an outpatient basis. Patients will receive doxycycline 100 mg twice daily for a period of 8 weeks (56 days). Upon registration (baseline) and at the first, third, and fifth days of doxycycline therapy, patients will be seen to obtain trough serum concentrations for pharmacokinetic studies. Additional serum levels will be checked on days 8, 15, 22 and 29.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 10.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Month 3 visitThe histopathologic response of the primary tumor will be assessed using the College of American Pathology criteria for residual tumor response following neoadjuvant therapy for the exocrine pancreas. Researchers will enumerate the number of observed dead/dying metakaryotes per 1 gram of resected pancreatic tissue.
Outcome measures
| Measure |
Doxycycline Administered to Patients
n=12 Participants
Patients will receive oral doxycycline and trough serum concentrations for pharmacokinetic studies will be obtained.
Doxycycline: Treatment with doxycycline hyclate will be administered as an oral agent on an outpatient basis. Patients will receive doxycycline 100 mg twice daily for a period of 8 weeks (56 days). Upon registration (baseline) and at the first, third, and fifth days of doxycycline therapy, patients will be seen to obtain trough serum concentrations for pharmacokinetic studies. Additional serum levels will be checked on days 8, 15, 22 and 29.
|
|---|---|
|
Determine the Efficacy of Doxycycline in Inducing Metakaryotic Cell Death in Primary Pancreatic Tumors as Measured by Pathologic Response
|
8.9 Cells/g
Standard Deviation 7.25
|
Adverse Events
Doxycycline Administered to Patients
Serious events: 9 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxycycline Administered to Patients
n=12 participants at risk
Patients will receive oral doxycycline and trough serum concentrations for pharmacokinetic studies will be obtained.
Doxycycline: Treatment with doxycycline hyclate will be administered as an oral agent on an outpatient basis. Patients will receive doxycycline 100 mg twice daily for a period of 8 weeks (56 days). Upon registration (baseline) and at the first, third, and fifth days of doxycycline therapy, patients will be seen to obtain trough serum concentrations for pharmacokinetic studies. Additional serum levels will be checked on days 8, 15, 22 and 29.
|
|---|---|
|
Immune system disorders
Anaphylaxis
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - other, specify
|
16.7%
2/12 • Number of events 2 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Gastrointestinal disorders
Ascities
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
Other adverse events
| Measure |
Doxycycline Administered to Patients
n=12 participants at risk
Patients will receive oral doxycycline and trough serum concentrations for pharmacokinetic studies will be obtained.
Doxycycline: Treatment with doxycycline hyclate will be administered as an oral agent on an outpatient basis. Patients will receive doxycycline 100 mg twice daily for a period of 8 weeks (56 days). Upon registration (baseline) and at the first, third, and fifth days of doxycycline therapy, patients will be seen to obtain trough serum concentrations for pharmacokinetic studies. Additional serum levels will be checked on days 8, 15, 22 and 29.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
2/12 • Number of events 2 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Gastrointestinal disorders
Ascities
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Gastrointestinal disorders
Vomitiing
|
8.3%
1/12 • Number of events 2 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Immune system disorders
Anaphylaxis
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Injury, poisoning and procedural complications
Pancreatic anastomotic leak
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Investigations
Lymphocyte count decreased
|
91.7%
11/12 • Number of events 18 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Investigations
Neutrophil count decreased
|
50.0%
6/12 • Number of events 7 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Investigations
Platelet count decreased
|
16.7%
2/12 • Number of events 2 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Investigations
White blood cell decreased
|
33.3%
4/12 • Number of events 6 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
2/12 • Number of events 2 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.3%
1/12 • Number of events 1 • Each participant was assessed from adverse events up to a maximum of 1 year.
|
Additional Information
Susan Tsai, MD
Froedtert and the Medical College of Wisconsin
Phone: 414-805-9720
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place