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Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bryostatin 1
paclitaxel
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Greater Baltimore Medical Center and Cancer Center
  • Comprehensive Cancer Center at Wake Forest University
  • Fox Chase Cancer Center
  • Wellspan Health - York Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
October 31, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005028
Brief Title
Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer
Official Title
Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2000 (Actual)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bryostatin 1
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arif Hussain, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Greater Baltimore Medical Center and Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Wellspan Health - York Cancer Center
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States

12. IPD Sharing Statement

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Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer

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