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| Sponsors and Collaborators: |
Oregon Health and Science University National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00459810 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: therapeutic estradiol Drug: paclitaxel poliglumex |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Stage IV disease
Evidence of disease progression (by PSA and/or imaging studies) despite standard hormonal therapy and after exposure to docetaxel-containing chemotherapy, as evidenced by any of the following:
Disease progression by PSA*, defined by 1 of the following:
Must have received prior therapy with at least two 3-weekly doses or six weekly doses of docetaxel
Serum testosterone < 50 ng/dL (unless surgically castrate)
PATIENT CHARACTERISTICS:
No significant cardiovascular illness, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 6 weeks since prior antiandrogen therapy (4 weeks for flutamide)
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Oregon | |
| Oregon Health and Science University Cancer Institute | |
| Portland, Oregon, United States, 97239-3098 | |
| Principal Investigator: | Tomasz M. Beer, MD | Oregon Health and Science University |
More Information
| Responsible Party: | Knight Cancer Institute at Oregon Health and Science University ( Tomasz M. Beer ) |
| Study ID Numbers: | CDR0000540438, OHSU-2656 |
| Study First Received: | April 11, 2007 |
| Last Updated: | April 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00459810 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
|
Prostatic Diseases Genital Neoplasms, Male Contraceptive Agents Hormone Antagonists Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Urogenital Neoplasms Estradiol 17 beta-cypionate Hormones Docetaxel Estradiol 3-benzoate Polyestradiol phosphate |
Estrogens Benzoates Antimitotic Agents Genital Diseases, Male Estradiol Recurrence Paclitaxel Tubulin Modulators Adenocarcinoma Prostatic Neoplasms Antineoplastic Agents, Phytogenic Androgens |
|
Molecular Mechanisms of Pharmacological Action Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents Contraceptive Agents Estradiol valerate Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Urogenital Neoplasms Estradiol 17 beta-cypionate Reproductive Control Agents Hormones Neoplasms by Site |
Estradiol 3-benzoate Therapeutic Uses Polyestradiol phosphate Estrogens Mitosis Modulators Antimitotic Agents Genital Diseases, Male Estradiol Pharmacologic Actions Neoplasms Paclitaxel Tubulin Modulators Antineoplastic Agents, Phytogenic Prostatic Neoplasms |