Trial Outcomes & Findings for Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer (NCT NCT00075504)
NCT ID: NCT00075504
Last Updated: 2015-09-28
Results Overview
Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR+PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2015-09-28
Participant Flow
A total of 35 patients were enrolled from 7 institutions between December 2003 and August 2007
A total of 2 patients did not receive treatment
Participant milestones
| Measure |
Stratum A Normal Liver Function Triapine, Gemcitabine
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
Stratum B Abnormal Liver Function Triapine, Gemcitabine
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
10
|
|
Overall Study
COMPLETED
|
14
|
3
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
Stratum A Normal Liver Function Triapine, Gemcitabine
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
Stratum B Abnormal Liver Function Triapine, Gemcitabine
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
Baseline Characteristics
Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer
Baseline characteristics by cohort
| Measure |
Stratum A Normal Liver Triapine, Gemcitabine
n=23 Participants
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
Stratum B Abnormal Liver Triapine, Gemcitabine
n=10 Participants
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=93 Participants
|
67.5 years
n=4 Participants
|
62.3 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
20 participants
n=93 Participants
|
10 participants
n=4 Participants
|
30 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=93 Participants
|
0 participants
n=4 Participants
|
2 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsTumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR+PR.
Outcome measures
| Measure |
Stratum A Normal Liver Function Triapine, Gemcitabine
n=23 Participants
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
Stratum B Abnormal Liver Function Triapine, Gemcitabine
n=10 Participants
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
|---|---|---|
|
Response Rate According to RECIST Criteria
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression.
Outcome measures
| Measure |
Stratum A Normal Liver Function Triapine, Gemcitabine
n=23 Participants
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
Stratum B Abnormal Liver Function Triapine, Gemcitabine
n=10 Participants
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
|---|---|---|
|
Progression Free Survival
|
3.7 months
Interval 2.7 to 5.8
|
3.6 months
Interval 1.9 to 11.6
|
SECONDARY outcome
Timeframe: Up to 2 yearsOutcome measures
| Measure |
Stratum A Normal Liver Function Triapine, Gemcitabine
n=23 Participants
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
Stratum B Abnormal Liver Function Triapine, Gemcitabine
n=10 Participants
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
|---|---|---|
|
Overall Survival
|
10.3 months
Interval 5.9 to
For stratum A the upper limit in the 95% CI for overall survival was not reached.
|
3.6 months
Interval 2.1 to 26.2
|
Adverse Events
Stratum A Normal Liver Function Triapine, Gemcitabine
Serious events: 21 serious events
Other events: 22 other events
Deaths: 0 deaths
Stratum B Abnormal Liver Function Triapine, Gemcitabine
Serious events: 10 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stratum A Normal Liver Function Triapine, Gemcitabine
n=23 participants at risk
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
Stratum B Abnormal Liver Function Triapine, Gemcitabine
n=10 participants at risk
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
|---|---|---|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 Neutrophils: Blood
|
0.00%
0/23
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
4.3%
1/23 • Number of events 1
|
30.0%
3/10 • Number of events 3
|
|
Investigations
Neutrophil count decreased
|
43.5%
10/23 • Number of events 10
|
40.0%
4/10 • Number of events 4
|
|
Blood and lymphatic system disorders
Anemia
|
21.7%
5/23 • Number of events 5
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fatigue
|
4.3%
1/23 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Platelet count decreased
|
21.7%
5/23 • Number of events 5
|
40.0%
4/10 • Number of events 4
|
|
Infections and infestations
Infection
|
30.4%
7/23 • Number of events 7
|
40.0%
4/10 • Number of events 4
|
|
Vascular disorders
Thromboembolic event
|
8.7%
2/23 • Number of events 2
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.7%
2/23 • Number of events 2
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/23
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/23
|
20.0%
2/10 • Number of events 2
|
Other adverse events
| Measure |
Stratum A Normal Liver Function Triapine, Gemcitabine
n=23 participants at risk
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
Stratum B Abnormal Liver Function Triapine, Gemcitabine
n=10 participants at risk
Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days
triapine: Given IV
gemcitabine: Given IV
|
|---|---|---|
|
Investigations
Platelet count decreased
|
47.8%
11/23 • Number of events 23
|
40.0%
4/10 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.7%
2/23 • Number of events 2
|
30.0%
3/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.7%
5/23 • Number of events 5
|
40.0%
4/10 • Number of events 4
|
|
Investigations
Lymphocyte count decreased
|
56.5%
13/23 • Number of events 13
|
40.0%
4/10 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin
|
82.6%
19/23 • Number of events 19
|
60.0%
6/10 • Number of events 6
|
|
Investigations
Alkaline phosphatase increase
|
26.1%
6/23 • Number of events 6
|
50.0%
5/10 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
30.4%
7/23 • Number of events 7
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Fatigue
|
47.8%
11/23 • Number of events 11
|
40.0%
4/10 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
43.5%
10/23 • Number of events 10
|
40.0%
4/10 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
17.4%
4/23 • Number of events 4
|
20.0%
2/10 • Number of events 2
|
Additional Information
Lisa Escobar-Peralta, Program Manager
Montefiore Medical Center
Phone: 718-379-6866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60