Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00459810|
Recruitment Status : Terminated
First Posted : April 13, 2007
Results First Posted : June 23, 2010
Last Update Posted : April 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: transdermal estradiol Drug: paclitaxel poliglumex||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
- Drug: transdermal estradiol
Transdermal estradiol given 0.2mg/day for duration of study.
- Drug: paclitaxel poliglumex
Paclitaxel poliglumex (PPX) is a macromolecular polymer-drug conjugate of paclitaxel. PPX was given every 28 days, at a dose of 150 mg/m2
- 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) ]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) ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|