Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estradiol may kill prostate cancer cells that no longer respond to hormone therapy. Giving paclitaxel poliglumex together with estradiol may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with estradiol works in treating patients with stage IV prostate cancer.
Drug: transdermal estradiol
Drug: paclitaxel poliglumex
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Paclitaxel Poliglumex (PPX) in Combination With Transdermal Estradiol for the Treatment of Androgen Independent Prostate Cancer After Docetaxel Chemotherapy|
- Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50% [ Time Frame: While receiving study agents (on average, 3 months) ] [ Designated as safety issue: No ]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.
- Measurable Disease Response Rate (Soft Tissue) [ Time Frame: While receiving study agents (on average, 3 months) ] [ Designated as safety issue: No ]Measurable disease response rate by RECIST criteria. Response is defined as at least a 30% decrease in the sum of the longest diameter in measurable lesions (larger than 10mm at baseline).
- Time to Disease Progression [ Time Frame: At time of progression by PSA or RECIST criteria ] [ Designated as safety issue: No ]Time from Day 1 to Day of meeting criteria for PSA or Measurable Disease Progression
- Time to Death [ Time Frame: Measured at Date of Death from any cause ] [ Designated as safety issue: No ]Defined as time from Day 1 of study regimen to Date of death from any cause.
- Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response [ Time Frame: Measured after 4 cycles of combination therapy ] [ Designated as safety issue: No ]These correlative analyses were not completed. As there were no PSA responses, it was not possible to correlate serum estradiol, serum cathepsin B, or bone turnover markers with PSA response.
|Study Start Date:||February 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Drug: transdermal estradiol
- 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 toxicity.
After completion of study therapy, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459810
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Principal Investigator:||Tomasz M. Beer, MD||OHSU Knight Cancer Institute|