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Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

Primary Purpose

Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paclitaxel
bryostatin 1
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acinar Cell Adenocarcinoma of the Pancreas

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologic proof of adenocarcinoma of the pancreas that is locally advanced and considered surgically not resectable or metastatic Patients with or without prior treatment are eligible for treatment on protocol; prior treatment may have included one treatment course of chemo/RT and/ or one course of chemotherapy, but not two prior courses of chemotherapy; Measurable disease ECOG performance status of 0-1 Ability to sign an informed consent form indicating awareness of the investigational nature of this study, in keeping with the policies of the hospital Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy; the most recent treatment for pancreatic cancer, within the limitations of allowed prior therapy must be 28 days or longer prior to enrollment on study Absolute granulocytes > 1,500/mm^3 Platelets > 150,000/mm^3 Serum bilirubin < 1.5 mg/dl Serum creatinine < 1.5 mg/dl Exclusion Criteria: Presence of any ongoing toxic effect from prior treatment Brain metastases History of active angina or myocardial infarction within 6 months; history of significant ventricular arrhythmia requiring medication with antiarrhythmics; well controlled atrial fibrillation on standard management will be permitted Pregnant or lactating women Pre-existing neurotoxicity that is graded 3+ or greater Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol HIV infection Any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in a clinical trial (for example a history of prior poor compliance with treatment)

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (paclitaxel, bryostatin 1)

Arm 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.

Outcomes

Primary Outcome Measures

Response Rate of at Least 30%
Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).

Secondary Outcome Measures

Number of Participants With Adverse Events
Overall Survival
Computed using the Kaplan-Meier estimator.

Full Information

First Posted
March 8, 2002
Last Updated
May 18, 2021
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00031694
Brief Title
Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer
Official Title
A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer. II. To determine the toxicity of therapy. III. To determine patient survival after therapy. IV. To determine Bryostatin-1 pharmacokinetics. OUTLINE: This is an open-label, multicenter study. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (paclitaxel, bryostatin 1)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, TAX, Taxol
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
bryostatin 1
Other Intervention Name(s)
B705008K112, BRYO, Bryostatin
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Response Rate of at Least 30%
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
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
Up to 8 years
Title
Overall Survival
Description
Computed using the Kaplan-Meier estimator.
Time Frame
Up to 8 years
Other Pre-specified Outcome Measures:
Title
Bryostatin 1 Pharmacokinetics
Description
Not done-study terminated early
Time Frame
Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic proof of adenocarcinoma of the pancreas that is locally advanced and considered surgically not resectable or metastatic Patients with or without prior treatment are eligible for treatment on protocol; prior treatment may have included one treatment course of chemo/RT and/ or one course of chemotherapy, but not two prior courses of chemotherapy; Measurable disease ECOG performance status of 0-1 Ability to sign an informed consent form indicating awareness of the investigational nature of this study, in keeping with the policies of the hospital Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy; the most recent treatment for pancreatic cancer, within the limitations of allowed prior therapy must be 28 days or longer prior to enrollment on study Absolute granulocytes > 1,500/mm^3 Platelets > 150,000/mm^3 Serum bilirubin < 1.5 mg/dl Serum creatinine < 1.5 mg/dl Exclusion Criteria: Presence of any ongoing toxic effect from prior treatment Brain metastases History of active angina or myocardial infarction within 6 months; history of significant ventricular arrhythmia requiring medication with antiarrhythmics; well controlled atrial fibrillation on standard management will be permitted Pregnant or lactating women Pre-existing neurotoxicity that is graded 3+ or greater Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol HIV infection Any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in a clinical trial (for example a history of prior poor compliance with treatment)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Kaubisch
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19738452
Citation
Lam AP, Sparano JA, Vinciguerra V, Ocean AJ, Christos P, Hochster H, Camacho F, Goel S, Mani S, Kaubisch A. Phase II study of paclitaxel plus the protein kinase C inhibitor bryostatin-1 in advanced pancreatic carcinoma. Am J Clin Oncol. 2010 Apr;33(2):121-4. doi: 10.1097/COC.0b013e3181a31920.
Results Reference
result

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Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

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