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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193232
• Other study ID #: SCRI GU 18
• Secondary ID: IIT16160
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: July 27, 2010
• Start date: May 2004
• Est. completion date: February 2007

Study information

• Verified date: July 2010
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2007
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel

• Bortezomib

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals, Millennium Pharmaceuticals, Inc.

References & Publications (1)

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. Cli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate
Secondary	progression-free survival
Secondary	overall survival