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

This study has been completed.
Aventis Pharmaceuticals
Millennium Pharmaceuticals, Inc.
Information provided by:
SCRI Development Innovations, LLC Identifier:
First received: September 12, 2005
Last updated: July 27, 2010
Last verified: July 2010
Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.

Condition Intervention Phase
Prostate Cancer Drug: Docetaxel Drug: Bortezomib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • objective response rate

Secondary Outcome Measures:
  • progression-free survival
  • overall survival

Estimated Enrollment: 50
Study Start Date: May 2004
Study Completion Date: February 2007
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
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.


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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00193232

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

Additional Information:
Publications: Identifier: NCT00193232     History of Changes
Other Study ID Numbers: SCRI GU 18
Study First Received: September 12, 2005
Last Updated: July 27, 2010

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 21, 2017