Paclitaxel And Bryostatin 1 In Treating Patients With Advanced Pancreatic Cancer

Study Overview

Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

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.

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.

Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer

DRUG: paclitaxel
DRUG: bryostatin 1

NCI-2012-03003
01-09-224 (OTHER Identifier) (OTHER: Montefiore Medical Center)
NCI-5624 (OTHER Identifier) (OTHER: CTEP)
N01CM17103 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-03-08	Results First Submitted 2015-04-08	Last Update Submitted that met QC Criteria 2021-05-18
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria 2015-04-08	Last Update Posted (ACTUAL) 2021-06-11
First Posted (ACTUAL) 2003-01-27	Results First Posted 2015-04-21	Last Verified 2021-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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.	DRUG: paclitaxel Given IV DRUG: bryostatin 1 Given IV

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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.

DRUG: paclitaxel

Given IV

DRUG: bryostatin 1

Given IV

Primary Outcome Measures	Measure Description	Time Frame
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).	Up to 8 years

Secondary Outcome Measures	Measure Description	Time Frame
Number of Participants With Adverse Events		Up to 8 years
Overall Survival	Computed using the Kaplan-Meier estimator.	Up to 8 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Andreas Kaubisch, Montefiore Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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Patients

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Clinical Trial Record