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Estramustine and Paclitaxel in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

2014-08-27 03:58:05 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining estramustine and paclitaxel in treating patients who have prostate cancer that has not responded to hormone therapy.

Description

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of paclitaxel with estramustine in patients with hormone refractory prostate cancer. II. Evaluate the toxicity of this combination at the MTD of paclitaxel in this patient population. III. Determine any objective tumor response arising from this treatment in these patients.

OUTLINE: This is a dose escalation study of paclitaxel. Patients receive oral estramustine daily on days 1-3 and paclitaxel IV over 1 hour on day 3 weekly for 6 weeks followed by 1 week of rest. Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: A minimum of 18 patients will be accrued for this study within 18 months.

Study Design

Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

estramustine phosphate sodium, paclitaxel

Location

Kaplan Cancer Center
New York
New York
United States
10016

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:05-0400

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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.

A family of highly conserved and widely expressed sodium-phosphate cotransporter proteins. They are electrogenic sodium-dependent transporters of phosphate that were originally identified as retroviral receptors in HUMANS and have been described in yeast and many other organisms.

A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.

A family of symporters that facilitate sodium-dependent membrane transport of phosphate.

A family of sodium-phosphate cotransporter proteins that also transport organic ANIONS. They are low affinity phosphate transporters.

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