A Phase II Study of Paclitaxel Poliglumex (PPX) in Combination With Transdermal Estradiol for the Treatment of Androgen Independent Prostate Cancer After Docetaxel Chemotherapy
- Determine the PSA response rate in patients with androgen independent metastatic
prostate cancer treated with paclitaxel poliglumex and transdermal estradiol.
- Determine the toxicity of this regimen in these patients.
- Determine the response rate in patients treated with this regimen.
- Determine the time to PSA progression and measurable disease progression in patients
treated with this regimen.
- Determine time to death from all causes in patients treated with this regimen.
- Correlate levels of serum estradiol, serum cathepsin B, and bone turnover markers with
PSA response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive transdermal estradiol continuously (patches changed every 7 days) until the
PSA level rises. Patients whose PSA increases above baseline or PSA decreases < 10% after 4
weeks of estradiol therapy or whose serum PSA reduction is < 50% after 12 weeks of estradiol
therapy also receive paclitaxel poliglumex therapy. These patients receive paclitaxel
poliglumex IV over 10-20 minutes on day 1. Treatment with paclitaxel poliglumex repeats
every 28 days for up to 10 courses in the absence of disease progression or unacceptable
After completion of study therapy, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%
PSA response rate is defined at the number of patients who experienced a PSA decline of equal to or greater than 50%, confirmed by a second measurement at least 4 weeks later.
While receiving study agents (on average, 3 months)
Tomasz M. Beer, MD
OHSU Knight Cancer Institute
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|OHSU Knight Cancer Institute||Portland, Oregon 97239|