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

This study has been completed.
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Millennium Pharmaceuticals, Inc.
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193232
First received: September 12, 2005
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

  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 ClinicalTrials.gov identifier: NCT00193232

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00193232     History of Changes
Other Study ID Numbers: SCRI GU 18, IIT16160
Study First Received: September 12, 2005
Last Updated: July 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014