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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Docetaxel

Intervention Type DRUG

Bortezomib

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No