Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005028
First received: April 6, 2000
Last updated: February 8, 2013
Last verified: November 2005
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: bryostatin 1
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 46
Study Start Date: May 2000
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

OBJECTIVES:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 6 months

Hematopoietic

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

Hepatic

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

Renal

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

Cardiovascular

  • 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)

Other

  • 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

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy (including paclitaxel)

Endocrine therapy

  • At least 4 weeks since prior steroids or megestrol

Radiotherapy

  • At least 4 weeks since prior radiotherapy to bone lesions

Other

  • No other concurrent investigational therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005028

Locations
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
Investigators
Study Chair: Arif Hussain, MD University of Maryland Greenebaum Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005028     History of Changes
Other Study ID Numbers: CDR0000067549, MSGCC-9948, NCI-50
Study First Received: April 6, 2000
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bryostatin 1
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 23, 2014