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Prostate CancerPhase 2NCT00024414

DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

A Phase 2 study testing DHA-paclitaxel in people with Prostate Cancer, run by Theradex at 8 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
DHA-paclitaxel
How many people
Not given
Where
8 sitesUnited States
Study dates
Apr 2001to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07019

  • Lucille Parker Markey Cancer Center, University of Kentucky

    Lexington, Kentucky, 40536-0098

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Arizona Oncology Associates

    Tucson, Arizona, 85712-2254

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
DHA-paclitaxel
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DHA-paclitaxelDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00024414
Sponsor's protocol ID
CDR0000068930
Other IDs
THERADEX-P01-00-04, JHOC-01011003, PROTARGA-P01-00-04
Status last verified
Mar 2003
First submitted
13 Sep 2001
Last updated
24 Jul 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DHA-paclitaxel in people with Prostate Cancer, run by Theradex at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2008.

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