AzTrials
AzTrials

Prostatic NeoplasmsPhase 2NCT00035113

EPO906 Therapy in Patients With Prostate Cancer

A Phase 2 study testing epothilone b in people with Prostatic Neoplasms, run by Novartis Pharmaceuticals at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause prostate cancer. Read more about this study

Who is it for?
Ages 18 to 85 years, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
epothilone b
How many people
48 participants
Where
5 sitesUnited States
Study dates
Jan 2002to Jan 2004
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 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The following patients may be eligible for this study:
  • Patients with any histologically proven prostate cancer with measurable metastatic disease or PSA progression > 20ng/ml after initial hormonal therapy will be eligible
  • Patients must be maintained on androgen ablation therapy with a LHRH agonist or have undergone orchiectomy
  • Patients in whom bicalutamide or flutamide has been recently withdrawn must demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively, beyond the discontinuation of such agents
  • Patients taking PC-SPES must discontinue therapy for a minimum of 4 weeks
  • For patients with disease progression defined solely by PSA increase: two consecutive rises in PSA measurement, over a 4-week period (each separated from the previous by 2 weeks) - the last measurement must be at least 50% greater than the nadir PSA achieved after the last therapeutic maneuver
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  • For patients who discontinued bicalutamide therapy prior to study entry, a third rising PSA measurement is required 2 weeks from the second PSA measurement (i.e. over a 6 week period)
  • Must have a life expectancy of greater than three (3) months
  • Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up to 2.5 X institutional upper limit of normal if alkaline phosphatase is less than the upper limit of normal, or alkaline phosphatase may be up to 4 X upper limit of normal if transaminases are less than or equal to the upper limit of normal
  • For patients with disease progression defined by measurable disease: changes in measurable size of lymph nodes or parenchymal masses on physical or radiologic examination (bone scan findings are not adequate to assess measurable disease).

Who cannot join

  • The following patients are not eligible for the study:
  • Patients with symptomatic CNS metastases or leptomeningeal involvement
  • Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
  • Patients with severe cardiac insufficiency
  • Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
  • Patients who received palliative radiotherapy to tumors located centrally less than 4 weeks (28 days) prior to planned enrollment date (palliative radiotherapy to isolated peripheral bone metastases is allowed)
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  • Patients experiencing hormone withdrawal syndrome, or are 28 days post-withdrawal of anti-androgen therapy (42 days for bicalutamide)
  • Patients who have had more than one prior chemotherapy regimen for hormone-resistant metastatic disease
  • Patients with disease measurable only by bone scan
  • Patients who have received corticosteroids within the past 28 days (may be waived with approval from Novartis)
  • History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer
  • Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry
  • Patients with radiation therapy or chemotherapy within the last four weeks
  • Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
  • HIV+ patients

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Maryland - Greenbaum Cancer Center

    Baltimore, Maryland, 21201

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Cancer Institute of New Jersey (CINJ)

    New Brunswick, New Jersey, 08901

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Androgen-independent Prostate Cancer

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause prostate cancer.

Being tested
epothilone b
Keywords
prostate cancer, prostate, androgen independent, cancer, tumor, tumour, neoplasm, carcinoma, intravenous, epothilone
Medical subject headings
Prostatic Neoplasms, Neoplasms, Carcinoma

What participants receive

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

  • epothilone bDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary outcomes (2)

  1. Time to progression

  2. Overall survival

Timeline

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

  1. First posted3 May 2002 (estimated)
  2. Study startJan 2002
  3. Primary completionJan 2004
  4. Study completionJan 2004

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00035113
Sponsor's protocol ID
CEPO906A2204
Status last verified
Feb 2017
First submitted
2 May 2002
Last updated
9 Feb 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing epothilone b in people with Prostatic Neoplasms, run by Novartis Pharmaceuticals at 5 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?

The sponsor lists 10 inclusion and 15 exclusion criteria. 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: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00035113.

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 9 Feb 2017.

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