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Sorafenib and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

2014-08-27 03:33:55 | BioPortfolio

Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how well it works in treating patients with metastatic androgen-independent prostate cancer.

Description

OBJECTIVES:

Primary

- To determine the proportion of patients achieving a 50% reduction in serum PSA from baseline in patients with androgen-independent prostate cancer (AIPC) receiving sorafenib tosylate and docetaxel.

Secondary

- To estimate the progression-free survival of patients with AIPC.

- To quantify the number and percent of patients who have stable disease at 6 months of therapy (failure to progress).

- To estimate median time to progression for all patients.

- To estimate the objective response rate of patients with AIPC treated with this regimen.

- To measure the percentage of patients surviving at 2 years.

- To determine the toxicities and estimate toxicity rates for patients treated with this regimen.

- To measure changes in tumor vasculature in response to therapy in selected patients with dynamic contrast-enhanced MRI (DCE-MRI) and correlate primary and secondary objectives to these measurement changes.

- To measure changes in serum HMGB1 in response to therapy and correlate primary and secondary objectives with these changes.

- To measure changes in serum cathepsin D in response to therapy and correlate primary and secondary objectives with these changes.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 2-19 and docetaxel IV on day 1. Treatment repeats every 21 days for up to 10 courses. Patients then receive oral sorafenib tosylate alone twice daily on days 1-19 with treatment repeating every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection periodically to measure serum HMGB1 and cathepsin D levels before and after therapy.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

docetaxel, sorafenib tosylate

Location

Abramson Cancer Center of the University of Pennsylvania
Philadelphia
Pennsylvania
United States
19104-4283

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:33:55-0400

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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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