A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer
Data Collection
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives