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Weekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00193232
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 28, 2010
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Millennium Pharmaceuticals, Inc.
Information provided by:
SCRI Development Innovations, LLC

Brief Summary:
Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel Drug: Bortezomib Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer
Study Start Date : May 2004
Actual Primary Completion Date : October 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. objective response rate

Secondary Outcome Measures :
  1. progression-free survival
  2. overall survival


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193232


Sponsors and Collaborators
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00193232     History of Changes
Other Study ID Numbers: SCRI GU 18
IIT16160
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Bortezomib
Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs