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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Sarah Cannon Research Institute Aventis Pharmaceuticals Millennium Pharmaceuticals, Inc.
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193232

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 II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

objective response rate

Secondary Outcome Measures:

progression-free survival
overall survival

Estimated Enrollment:	50
Study Start Date:	May 2004

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193232

Sponsors and Collaborators

Sarah Cannon Research Institute

Aventis Pharmaceuticals

Millennium Pharmaceuticals, Inc.

Investigators

Principal Investigator:

John D. Hainsworth, MD

Sarah Cannon Research Institute

More Information

Publications of Results:

Hainsworth JD, Meluch AA, Spigel DR, Barton J Jr, Simons L, Meng C, Gould B, Greco FA. Weekly docetaxel and bortezomib as first-line treatment for patients with hormone-refractory prostate cancer: a Minnie Pearl Cancer Research Network phase II trial. Clin Genitourin Cancer. 2007 Mar;5(4):278-83.

Study ID Numbers:	SCRI GU 18, IIT16160
Study First Received:	September 12, 2005
Last Updated:	October 5, 2007
ClinicalTrials.gov Identifier:	NCT00193232
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
Prostatic Diseases
Genital Neoplasms, Male
Bortezomib

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009