Advertisement

Topics

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

Clinical Trials [3433 Associated Clinical Trials listed on BioPortfolio]

Sorafenib Tosylate With or Without Pravastatin in Treating Patients With Liver Cancer and Cirrhosis

RATIONALE: Sorafenib tosylate and pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of live...

Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying the effectiveness of sorafenib in trea...

Sorafenib Tosylate and Pembrolizumab in Treating Patients With Advanced or Metastatic Liver Cancer

This phase Ib/II trial studies how well sorafenib tosylate and pembrolizumab work in treating patients with liver cancer that has spread to other parts of the body. Sorafenib tosylate may ...

Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,...

Temsirolimus and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer and Liver Dysfunction

RATIONALE: Temsirolimus and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus together with sorafenib tosyla...

PubMed Articles [13634 Associated PubMed Articles listed on BioPortfolio]

The efficacy and safety comparison of docetaxel, cabazitaxel, estramustine, and mitoxantrone for castration-resistant prostate cancer: A network meta-analysis.

The aim of this study was to compare the efficacy and safety of docetaxel, cabazitaxel, docetaxel + estramustine, mitoxantrone in the management of castration-resistant prostate cancer (CRPC).

The Role of YKL-40 in Predicting Resistance to Docetaxel Chemotherapy in Prostate Cancer.

High baseline YKL-40 serum levels are associated with drug resistance in several solid tumours. However, their role in predicting docetaxel (DOC) resistance in prostate cancer (PCa) is unknown.

Novel CIL-102 Derivatives as Potential Therapeutic Agents for Docetaxel-Resistant Prostate Cancer.

The standard-of-care treatment for metastatic prostate cancer (PCa) is androgen deprivation therapy (ADT). Nevertheless, most of those tumors eventually relapse and develop into lethal castration-resi...

Phase II randomized study of radiotherapy and three-year androgen deprivation with or without concurrent weekly docetaxel in high-risk localized prostate cancer patients.

Docetaxel improves survival in patients with metastatic prostate cancer (PC). This randomized phase II trial aimed to assess the activity of weekly docetaxel with radiotherapy (RT) plus androgen depri...

Qualitative and Quantitative Assessment of Patient and Carer Experience of Chemotherapy (Docetaxel) in Combination with Androgen Deprivation Therapy (ADT) for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

Recent studies suggest that docetaxel plus androgen deprivation therapy can prolong survival among men with metastatic hormone-sensitive prostate cancer (mHSPC). However, as a cytotoxic therapy, there...

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.

More From BioPortfolio on "Sorafenib and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Prostate Cancer
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial