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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Docetaxel

Drug: Bortezomib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193232

IIT16160

SCRI GU 18

Details and patient eligibility

About

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

Full 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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.