Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate 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: NCT00005028
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : March 30, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Maryland

Brief Summary:
Phase II trial to study the effectiveness of combining paclitaxel and bryostatin 1 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: bryostatin 1 Drug: paclitaxel Phase 2

Detailed Description:


I. Determine the onset, duration, and degree of response in patients with hormone-refractory, metastatic adenocarcinoma of the prostate treated with paclitaxel and bryostatin 1.

II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 6 months and then every 3 months thereafter.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer
Actual Study Start Date : May 2000
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm I
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: bryostatin 1 Drug: paclitaxel

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic adenocarcinoma of the prostate that failed first- or second-line hormonal therapy (e.g., gonadal androgen suppression [orchiectomy or luteinizing hormone-releasing hormone] with or without antiandrogens)

    • Failure on hormonal therapy is defined by 1 of the following criteria:

      • Biochemical progression (after withdrawal of antiandrogens), documented by 3 rising PSA values, each value measured at least 2 weeks apart, with the last measurement being at least 25% of the nadir achieved while on hormonal therapy and with an increase in the absolute value by at least 5 ng/mL
      • Measurable disease progression, defined by an increase in the sum of the products of the perpendicular diameters of any measurable lesion(s) by at least 25%
  • Bone only progression allowed only with concurrent biochemical progression
  • Castrate levels of testosterone (no greater than 50 ng/dL)
  • No clinical signs/symptoms suggesting CNS metastases



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 6 months


  • WBC at least 3,000/mm^3
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 times ULN
  • Calcium no greater than ULN


  • No uncontrolled or severe cardiovascular disease
  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No angina pectoris
  • No active thromboembolic events within the past 3 months (e.g., deep venous thrombosis or cerebrovascular accident)


  • No other serious medical or psychiatric illness
  • No active infection
  • No dementia or significantly altered mental status
  • No prior or concurrent grade 1 or greater peripheral neuropathy
  • No other prior or concurrent malignancy within the past 5 years except curatively treated nonmelanoma skin cancer
  • HIV negative
  • Fertile patients must use effective contraception



  • No prior chemotherapy (including paclitaxel)

Endocrine therapy

  • At least 4 weeks since prior steroids or megestrol


  • At least 4 weeks since prior radiotherapy to bone lesions


  • No other concurrent investigational therapy

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): NCT00005028

United States, Maryland
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Wellspan Health - York Cancer Center
York, Pennsylvania, United States, 17403
Sponsors and Collaborators
University of Maryland
National Cancer Institute (NCI)
Study Chair: Arif Hussain, MD University of Maryland Greenebaum Cancer Center

Responsible Party: University of Maryland Identifier: NCT00005028     History of Changes
Other Study ID Numbers: MSGCC-9948
CDR0000067549 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by University of Maryland:
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bryostatin 1
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs