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Ketoconazole and Docetaxel in Treating Patients With Metastatic Prostate Cancer

2014-08-27 03:56:00 | BioPortfolio

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ketoconazole with docetaxel may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining ketoconazole with docetaxel in treating patients who have metastatic prostate cancer.

Description

OBJECTIVES:

- Determine the maximum tolerated dose and recommended phase II dose of ketoconazole when administered in combination with docetaxel in patients with metastatic androgen-independent prostate cancer.

- Determine the side effect profile of this regimen in these patients.

- Determine the pharmacokinetics of this regimen in these patients.

- Determine any clinical activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of docetaxel.

Patients receive docetaxel IV over 1 hour once weekly on days 1, 8, and 18 and oral ketoconazole three times daily on days 15-28 for the first course. For the second and subsequent courses, patients receive docetaxel IV on days 1, 8, and 15 and oral ketoconazole daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: Approximately 3-55 patients will be accrued for this study within 2 years.

Study Design

Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

docetaxel, ketoconazole

Location

NCI - Center for Cancer Research
Bethesda
Maryland
United States
20892-8200

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:00-0400

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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 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.

Tumors or cancer of the PROSTATE.

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