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Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer

NCT00031694•National Cancer Institute (NCI)

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.

Eligibility

Age

19 - No limit years

Sex

ALL

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)

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

Key Dates

Start Date

March 1, 2002

Primary Completion Date

April 1, 2010

Completion Date

April 1, 2010

Last Updated

June 11, 2021

Enrollment

ACTUAL participants

Conditions

Acinar Cell Adenocarcinoma of the PancreasDuct Cell Adenocarcinoma of the PancreasRecurrent Pancreatic CancerStage III Pancreatic CancerStage IV Pancreatic Cancer

Interventions

paclitaxel

DRUG

bryostatin 1

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Pancreatic Cancer Diagnosis With FAPI-PET Imaging

CPI-613 and Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer

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