DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024414
First received: September 13, 2001
Last updated: July 23, 2008
Last verified: March 2003
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: DHA-paclitaxel
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Study Start Date: April 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  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: NCT00024414

Locations
United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States, 85712-2254
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
United States, Kentucky
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0098
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07019
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, Pennsylvania
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Sponsors and Collaborators
Theradex
Investigators
Study Chair: Michael A. Carducci, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00024414     History of Changes
Other Study ID Numbers: CDR0000068930, THERADEX-P01-00-04, JHOC-01011003, PROTARGA-P01-00-04
Study First Received: September 13, 2001
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

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
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014