Prostate Cancer
Conditions
Brief summary
Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.
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.
Interventions
DRUGDocetaxel
DRUGBortezomib
Sponsors
Aventis Pharmaceuticals
Millennium Pharmaceuticals, Inc.
SCRI Development Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
| overall survival | — |
Outcome results
None listed