Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma
- Conditions
- Prostate Cancer
- Registration Number
- NCT00193193
- Lead Sponsor
- SCRI Development Innovations, LLC
- Brief Summary
In this trial we will investigate how this three-drug regimen may be improved, both with respect to efficacy and toxicity, by making some modifications in the dosing and schedule in the treatment of patients with hormone refractory prostate cancer.
- Detailed Description
Upon determination of eligibility, patients will receive:
Paclitaxel + Estramustine + Carboplatin
Patients will receive weekly paclitaxel and low-dose estramustine, in combination with carboplatin administered either weekly r every four weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Adenocarcinoma of the prostate not curable with local treatment
- Disease progression while receiving hormonal therapy
- Measurable or evaluable disease
- Previous treatment with a maximum of one prior chemotherapy regimen
- ECOG performance status 0, 1, or 2.
- Adequate bone marrow, liver and kidney function
- Able to comprehend the nature of this study and give written informed consent
You cannot participate in this study if any of the following apply to you:
- Age < 18 years
- History of treatment for an invasive malignancy within five years
- Significant heart disease
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall response rate
- Secondary Outcome Measures
Name Time Method Toxicity Overall survival