Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00031694
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 21, 2015
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Interventions Drug: paclitaxel
Drug: bryostatin 1
Enrollment 19
Recruitment Details A total of 19 patients were enrolled from 5 centers between March 2002 and October 2003.
Pre-assignment Details  
Arm/Group Title Treatment (Paclitaxel, Bryostatin 1)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 19
Completed 0
Not Completed 19
Reason Not Completed
Adverse Event             12
Death             2
Withdrawal by Subject             5
Arm/Group Title Treatment (Paclitaxel, Bryostatin 1)
Hide Arm/Group Description

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 Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
56.0
(21 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
7
  36.8%
Male
12
  63.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
Non-Hispanic whites 13
Non-Hispanic black 3
Hispanic 3
1.Primary Outcome
Title Response Rate of at Least 30%
Hide Description Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame Up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Paclitaxel, Bryostatin 1)
Hide Arm/Group Description:

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 Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Adverse Events
Hide Description 95% confidence intervals will be computed and presented.
Time Frame Up to 8 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Survival
Hide Description Computed using the Kaplan-Meier estimator.
Time Frame Up to 8 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Bryostatin 1 Pharmacokinetics
Hide Description [Not Specified]
Time Frame Week 1
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Paclitaxel, Bryostatin 1)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Paclitaxel, Bryostatin 1)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Paclitaxel, Bryostatin 1)
Affected / at Risk (%)
Total   10/19 (52.63%) 
Blood and lymphatic system disorders   
Leukopenia  1  5/19 (26.32%) 
Anemia  1  2/19 (10.53%) 
General disorders   
Death  1  2/19 (10.53%) 
Abdominal pain  1  2/19 (10.53%) 
Hepatobiliary disorders   
ALT/SGPT  1  2/19 (10.53%) 
AST/SGOT  1  2/19 (10.53%) 
Infections and infestations   
Infection  1  2/19 (10.53%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  2/19 (10.53%) 
Vascular disorders   
Thrombosis/embolism  1  2/19 (10.53%) 
Hemorrhage  1  2/19 (10.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Paclitaxel, Bryostatin 1)
Affected / at Risk (%)
Total   7/19 (36.84%) 
Blood and lymphatic system disorders   
Leukopenia  1  1/19 (5.26%) 
Anemia  1  4/19 (21.05%) 
General disorders   
Abdominal pain  1  3/19 (15.79%) 
Infections and infestations   
Infection  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  7/19 (36.84%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: NYCC Regulatory Coordinator
Organization: Montefiore Medical Center-New York cancer Consortium
Phone: 7183796862
EMail: sforde@montefiore.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031694     History of Changes
Other Study ID Numbers: NCI-2012-03003
01-09-224 ( Other Identifier: Montefiore Medical Center )
NCI-5624 ( Other Identifier: CTEP )
N01CM17103 ( U.S. NIH Grant/Contract )
First Submitted: March 8, 2002
First Posted: January 27, 2003
Results First Submitted: April 8, 2015
Results First Posted: April 21, 2015
Last Update Posted: April 21, 2015