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DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DHA-paclitaxel
Sponsored by
Theradex
About
Eligibility
Locations
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 or cytologically confirmed adenocarcinoma of the prostate Progressive metastatic disease on continuous hormonal therapy (e.g., orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist) Progressive disease is defined by all of the following: Measurable disease or lesions on bone scan Increases in prostate-specific antigen (PSA) levels on at least 2 consecutive measurements Continued PSA elevation after cessation of prior antiandrogen therapy (4 weeks after flutamide and nilutamide and 8 weeks after bicalutamide) PSA level at least 5 ng/mL Serum testosterone level less than 50 ng/mL Patients who have not undergone prior surgical castration should continue primary androgen suppression (LHRH agonist) No known or clinical evidence of CNS metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil 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) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled ventricular arrhythmia No myocardial infarction within the past 3 months No superior vena cava syndrome Neurologic: No peripheral neuropathy greater than grade 1 No uncontrolled major seizure disorder No spinal cord compression Other: No psychiatric disorder that would preclude informed consent No unstable or serious concurrent medical condition No concurrent serious infection requiring parenteral therapy No other prior or concurrent malignancy except: Curatively treated nonmelanoma skin cancer OR Other cancer curatively treated with surgery alone that has not recurred for more than 5 years Fertile patients must use effective contraception during and for at least 6 months after study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior taxanes Prior mitoxantrone or prednisone for metastatic disease allowed At least 28 days since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy Radiotherapy: No prior samarium SM 153 lexidronam pentasodium or strontium chloride Sr 89 Prior external radiotherapy for metastatic disease allowed At least 28 days since prior large-field radiotherapy and recovered No concurrent radiotherapy, including whole-brain radiotherapy for documented CNS metastasis Surgery: See Disease Characteristics At least 14 days since prior major surgery and recovered Other: No other prior nonhormonal treatment for metastatic disease At least 28 days since prior herbal preparations (e.g., PC-SPES) and recovered No other concurrent anticancer medications

Sites / Locations

  • Arizona Oncology Associates
  • Alta Bates Comprehensive Cancer Center
  • Lucille Parker Markey Cancer Center, University of Kentucky
  • Louisiana State University Health Sciences Center - Shreveport
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Veterans Affairs Medical Center - East Orange
  • Herbert Irving Comprehensive Cancer Center
  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
July 23, 2008
Sponsor
Theradex
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1. Study Identification

Unique Protocol Identification Number
NCT00024414
Brief Title
DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
Official Title
Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Unknown status
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Theradex

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Detailed Description
OBJECTIVES: Determine the objective tumor response rate or prostate-specific antigen response, duration of response, and time to disease progression in patients with metastatic hormone-refractory prostate cancer treated with DHA-paclitaxel. Determine the overall survival of patients treated with this drug. Determine the toxicity profile of this drug in these patients. Assess the quality of life of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and off study. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 18-50 patients will be accrued for this study.

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DHA-paclitaxel

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the prostate Progressive metastatic disease on continuous hormonal therapy (e.g., orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist) Progressive disease is defined by all of the following: Measurable disease or lesions on bone scan Increases in prostate-specific antigen (PSA) levels on at least 2 consecutive measurements Continued PSA elevation after cessation of prior antiandrogen therapy (4 weeks after flutamide and nilutamide and 8 weeks after bicalutamide) PSA level at least 5 ng/mL Serum testosterone level less than 50 ng/mL Patients who have not undergone prior surgical castration should continue primary androgen suppression (LHRH agonist) No known or clinical evidence of CNS metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil 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) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled ventricular arrhythmia No myocardial infarction within the past 3 months No superior vena cava syndrome Neurologic: No peripheral neuropathy greater than grade 1 No uncontrolled major seizure disorder No spinal cord compression Other: No psychiatric disorder that would preclude informed consent No unstable or serious concurrent medical condition No concurrent serious infection requiring parenteral therapy No other prior or concurrent malignancy except: Curatively treated nonmelanoma skin cancer OR Other cancer curatively treated with surgery alone that has not recurred for more than 5 years Fertile patients must use effective contraception during and for at least 6 months after study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior taxanes Prior mitoxantrone or prednisone for metastatic disease allowed At least 28 days since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy Radiotherapy: No prior samarium SM 153 lexidronam pentasodium or strontium chloride Sr 89 Prior external radiotherapy for metastatic disease allowed At least 28 days since prior large-field radiotherapy and recovered No concurrent radiotherapy, including whole-brain radiotherapy for documented CNS metastasis Surgery: See Disease Characteristics At least 14 days since prior major surgery and recovered Other: No other prior nonhormonal treatment for metastatic disease At least 28 days since prior herbal preparations (e.g., PC-SPES) and recovered No other concurrent anticancer medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Carducci, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712-2254
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Lucille Parker Markey Cancer Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0098
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07019
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States

12. IPD Sharing Statement

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DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

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