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Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer

2014-07-24 14:21:47 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- Determine the PSA response rate in patients with androgen independent metastatic prostate cancer treated with paclitaxel poliglumex and transdermal estradiol.

Secondary

- 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

transdermal estradiol, paclitaxel poliglumex

Location

UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco
California
United States
94115

Status

Active, not recruiting

Source

OHSU Knight Cancer Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:21:47-0400

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Medical and Biotech [MESH] Definitions

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

Steroidal compounds related to ESTRADIOL, the major mammalian female sex hormone. Estradiol congeners include important estradiol precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with estrogenic activities.

A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.

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