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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. Identifier: NCT00031694
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 21, 2015
Last Update Posted : April 21, 2015
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
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 Phase 2

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer
Study Start Date : January 2002
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol

Drug: bryostatin 1
Given IV
Other Names:
  • B705008K112
  • BRYO
  • Bryostatin

Primary Outcome Measures :
  1. Response Rate of at Least 30% [ Time Frame: Up to 8 years ]
    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 :
  1. Adverse Events [ Time Frame: Up to 8 years ]
    95% confidence intervals will be computed and presented.

  2. Overall Survival [ Time Frame: Up to 8 years ]
    Computed using the Kaplan-Meier estimator.

  3. Bryostatin 1 Pharmacokinetics [ Time Frame: Week 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00031694

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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Andreas Kaubisch Montefiore Medical Center

Publications of Results:
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00031694    
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 Posted: January 27, 2003    Key Record Dates
Results First Posted: April 21, 2015
Last Update Posted: April 21, 2015
Last Verified: May 2013
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Carcinoma, Acinar Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Albumin-Bound Paclitaxel
Bryostatin 1
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs