Trial Outcomes & Findings for Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer (NCT NCT00031694)
NCT ID: NCT00031694
Last Updated: 2021-06-11
Results Overview
Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 8 years
Results posted on
2021-06-11
Participant Flow
A total of 19 patients were enrolled from 5 centers between March 2002 and October 2003.
Participant milestones
| Measure |
Treatment (Paclitaxel, Bryostatin 1)
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Treatment (Paclitaxel, Bryostatin 1)
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel, Bryostatin 1)
n=19 Participants
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Age, Continuous
|
56.0 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic whites
|
13 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic black
|
3 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 8 yearsPopulation: data not met
Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome measures
| Measure |
Treatment (Paclitaxel, Bryostatin 1)
n=19 Participants
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Response Rate of at Least 30%
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 8 yearsOutcome measures
| Measure |
Treatment (Paclitaxel, Bryostatin 1)
n=19 Participants
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Number of Participants With Adverse Events
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 8 yearsPopulation: Patients with locally advanced or metastatic pancreatic adenocarcinoma received a total of 52 cycles of therapy.
Computed using the Kaplan-Meier estimator.
Outcome measures
| Measure |
Treatment (Paclitaxel, Bryostatin 1)
n=19 Participants
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Overall Survival
|
17 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1Not done-study terminated early
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Paclitaxel, Bryostatin 1)
Serious events: 10 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Paclitaxel, Bryostatin 1)
n=19 participants at risk
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
26.3%
5/19
|
|
Blood and lymphatic system disorders
Anemia
|
10.5%
2/19
|
|
General disorders
Death
|
10.5%
2/19
|
|
General disorders
Abdominal pain
|
10.5%
2/19
|
|
Infections and infestations
Infection
|
10.5%
2/19
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
2/19
|
|
Vascular disorders
Thrombosis/embolism
|
10.5%
2/19
|
|
Vascular disorders
Hemorrhage
|
10.5%
2/19
|
|
Hepatobiliary disorders
ALT/SGPT
|
10.5%
2/19
|
|
Hepatobiliary disorders
AST/SGOT
|
10.5%
2/19
|
Other adverse events
| Measure |
Treatment (Paclitaxel, Bryostatin 1)
n=19 participants at risk
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
paclitaxel: Given IV
bryostatin 1: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
1/19
|
|
Blood and lymphatic system disorders
Anemia
|
21.1%
4/19
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
36.8%
7/19
|
|
General disorders
Abdominal pain
|
15.8%
3/19
|
|
Infections and infestations
Infection
|
5.3%
1/19
|
Additional Information
Joseph Sparano
Montefiore Medical Center-New York cancer Consortium
Phone: 718-405-8404
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60