Prostate Cancer
Conditions
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.
Interventions
Sponsors
Bristol-Myers Squibb
SCRI Development Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | — |
| Overall survival | — |
Outcome results
None listed