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A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer


Upon determination of eligibility, patients will be receive:

- Docetaxel + Bortezomib

Patients with objective responses or stable disease will continue treatment for eight
courses or until disease progression is documented.


Inclusion Criteria:



- Prostate cancer, and objective evidence of metastatic disease

- Progression while receiving androgen ablation therapy

- No previous chemotherapy

- Measurable or evaluable disease in conjunction with elevated serum PSA levels

- ECOG performance status 0, 1, or 2

- Adequate bone marrow, liver and kidney function

- Voluntarily provide written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

- Moderate or severe peripheral neuropathy

- Age < 18 years

- Other serious medical conditions that may interfere with protocol therapy

- Other active malignancies

- history of treatment for other invasive cancers within 3 years

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

objective response rate

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI GU 18

NCT ID:

NCT00193232

Start Date:

May 2004

Completion Date:

February 2007

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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