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Prostate CancerPhase 2NCT00136526

Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer

A Phase 2 study testing Docetaxel and Diethylstilbestrol (DES) in people with Prostate Cancer, run by University of Washington.

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 is for men who have prostate cancer that has spread outside of the prostate gland and is no longer responding to hormone removal therapy. This study is designed to determine if a new drug combination will help to control the cancer. Read more about this study

Who is it for?
Ages 21 to 83 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Docetaxel and Diethylstilbestrol (DES)
How many people
30 participants
Where
No sites listed yet
Study dates
Dec 2002to Oct 2007
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 21 to 83 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients meeting all of the following criteria are eligible for the trial:
  • Men 18 years of age or older with a histologically confirmed diagnosis of adenocarcinoma of the prostate consistent with stage D3.
  • Prior therapy with medical or surgical castration and evidence of castrate levels of testosterone
  • Discontinuation of nonsteroidal antiandrogens more than 6 weeks prior to evaluation for progression. It is not a requirement that nonsteroidal antiandrogen therapy be used prior to enrollment.
  • Androgen independent disease as defined by one of the following after androgen ablation and withdrawal from nonsteroidal antiandrogen if initiated (> 6 weeks after discontinuation):
  • PSA must be greater than 5 ng/ml and increasing as demonstrated by two consecutive increasing PSA levels over 5 ng/ml. Each PSA measurement must be taken at least one week apart.
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  • Increase in measurable disease within one month of enrollment
  • Worsening of bone scan abnormalities within two months of enrollment and greater than four months since initiation of luteinizing hormone-releasing hormone (LHRH) agonist.
  • Performance status < 3 by the Eastern Cooperative Oncology Group (ECOG) scale.
  • Patients must be informed of the investigational nature of the study and sign an informed consent form.
  • Life expectancy must be >= 3 months.
  • Laboratory values must be as follows:
  • White blood cell count: >= 3,000/mm3
  • Absolute granulocyte count: >= 1,500/mm3
  • Platelets: >= 100,000/mm3
  • Hemoglobin: >= 8g/dL
  • Serum creatinine: <= 1.5 x upper limit of normal (ULN)
  • AST: <= 2 x ULN
  • ALT: <= 2 x ULN
  • Serum calcium: <= ULN
  • Total bilirubin: <= 1.5 x ULN
  • Patient must be willing to consent to using effective contraception while on treatment and for three months after completion of therapy.

Who cannot join

  • Patients meeting any of the following criteria will not be eligible for the trial:
  • Patients who have received PC-SPES, DES, mitoxantrone or docetaxel therapy.
  • Patients who have received prior chemotherapy of any type or are receiving any other investigational therapy.
  • Patients with evidence of recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure.
  • Patients with a prior history of myocardial infarction, pulmonary embolism, cerebral vascular accident (CVA) or atrial fibrillation.
  • Patients with evidence of active angina as evidenced by chest pain responsive to sublingual nitroglycerin or other anginal equivalent.
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  • Patients with known evidence of brain metastases or carcinomatous meningitis.
  • Patients with a history of other cancers except curatively-treated non-melanomatous skin cancer. Other cured tumors may be entered after discussion with and approval of the study chair.
  • Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
  • Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.
  • Histologic evidence of small cell carcinoma of the prostate.
  • Patients with current peripheral neuropathy of any etiology that is greater than Grade I.
  • Patients with contraindications to anti-coagulation.

About this study

Official title: Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer: A Phase II Study

This study is for men who have prostate cancer that has spread outside of the prostate gland and is no longer responding to hormone removal therapy. This study is designed to determine if a new drug combination will help to control the cancer. The medicines being used, docetaxel and diethylstilbestrol (DES), have been given to patients with prostate cancer and each drug has demonstrated activity in prostate cancer, either used alone or in other combinations. The objective of this study is to determine the effect of this drug combination on the prostate cancer and its response to disease progression.

Read the detailed description

This is a single arm phase II trial of docetaxel and diethylstilbestrol for patients with symptomatic stage D3 androgen independent prostate cancer. Patients will receive docetaxel weekly for 10 cycles (each cycle consists of treatment for 3 weeks out of every 4) and DES daily for 40 weeks or until there is evidence of disease progression, whichever occurs first. Patients will be followed to determine PSA and objective response. Additional endpoints include time to progression, disease specific survival and overall survival. Disease progression will be defined as 2 consecutive increases in PSA and/or tumor growth as evidenced by examination or radiologic evaluation. Other secondary objectives will be to determine the toxicity, and impact on quality of life of this regimen.

Conditions
Prostate Cancer
Being tested
Docetaxel and Diethylstilbestrol (DES)
Keywords
Prostate Cancer, Hormone refractory prostate cancer, Metastatic 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.

  • Docetaxel and Diethylstilbestrol (DES)Drug

    Subjects receive docetaxel 36 Mg/m2weekly for ten cycles (3 weeks out of every 4) and DES 1 mg daily for 40 weeks or until there is evidence of disease progression, whichever occurs first.

What is being measured

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

  1. Monthly PSA levels and scans every 3 months while on therapy

    Measured: Over 10 months

Secondary outcomes (3)

  1. To evaluate the time to progression of disease

    Measured: Follow-up until progression

  2. To determine the risk of cardiovascular complications associated with DES plus aspirin and warfarin 2 mg daily

    Measured: Over 10 months while on therapy

  3. To measure this regimen's toxicity and impact on quality of life measures

    Measured: Over 10 months while on therapy

Timeline

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

  1. First posted29 Aug 2005 (estimated)
  2. Study startDec 2002
  3. Study completionOct 2007

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00136526
Sponsor's protocol ID
02-4599-V
Other IDs
FHCRC-UW-02-4599-V
Status last verified
May 2013
First submitted
25 Aug 2005
Last updated
9 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel and Diethylstilbestrol (DES) in people with Prostate Cancer, run by University of Washington.

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 22 inclusion and 14 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 May 2013. Status can change between updates, so confirm with the study contact before making plans.

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?

Monthly PSA levels and scans every 3 months while on therapy (time frame: Over 10 months). 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 NCT00136526.

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 May 2013.

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