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OpenTrials
Completed

NCT Number: NCT00193232

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

bortezomib

Drug

Primary outcomes

  1. objective response rate

Secondary outcomes

  1. progression-free survival

  2. overall survival

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Aventis Pharmaceuticals
  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Jul 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.