DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

July 23, 2008 updated by: Theradex

Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712-2254
        • Arizona Oncology Associates
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0098
        • Lucille Parker Markey Cancer Center, University of Kentucky
    • Louisiana
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • New Jersey
      • East Orange, New Jersey, United States, 07019
        • Veterans Affairs Medical Center - East Orange
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theradex

Investigators

  • Study Chair: Michael A. Carducci, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068930
  • THERADEX-P01-00-04
  • JHOC-01011003
  • PROTARGA-P01-00-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on DHA-paclitaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe