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.
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
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.
- First posted27 Jan 2003 (estimated)
- Study startApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Theradex
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael A. Carducci, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00024414
- Acronym / sponsor ID
- CDR0000068930
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- TheradexIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA-paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A. Carducci, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
8 sites in 1 country: see every site and its status.
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.