A Study to Test the Safety & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer

03:56 EDT 22nd August 2014 | BioPortfolio

Summary

Prostate cancer is a common and important health issue. Although effective treatment is often available for localized disease, metastatic prostate cancer remains incurable. The initial treatment for metastatic prostate cancer often includes medical or surgical treatments that deprive the tumor of male hormones (androgens) required for growth. Although this treatment is successful for many patients, the cancer may eventually return in others. Recurrent prostate cancer may be treated with additional hormonal agents, but these agents usually do not result in long-term control of the disease. Eventually most patients with recurrent prostate cancer progress to a state where the cancer grows despite very low level of circulating male hormones known as androgen independent prostate cancer (AIPC).

Description

Patients will undergo a screening procedure to determine eligibility of trial. During the treatment period, the patient will be given docetaxel/bevacizumab on day 1 followed by RAD001 continuously on days 2-21 and this is called a treatment cycle. Patients will be able to continue to receive multiple treatment courses as long as the cancer does not get worse and the person does not develop other problems that would prevent him from staying in the study. The final part of the research is the study completion period which includes an end of treatment visit and subsequent follow-up visits. These visits take place whenever the research medication is stopped, even if it is stopped early. For the patient's safety, he/she should at least complete the end of treatment visit.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

RAD001, Docetaxel, Bevacizumab

Location

Westside Prostate Cancer Center, University of Southern California
Beverly Hills
California
United States
90211

Status

Recruiting

Source

USC/Norris Comprehensive Cancer Center

Results (where available)

View Results

Links

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RAD001 and Bicalutamide for Androgen Independent Prostate Cancer

The goal of this clinical trial is to learn if the study drug RAD001 in combination with Bicalutamide can slow the growth of prostate cancer. The safety of RAD001 given together with Bica...

Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

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Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy

The main purpose of this trial is to collect information and to evaluate the effects, good or bad, the combination of docetaxel and bevacizumab has on patients with high risk prostate canc...

Docetaxel, Thalidomide, Prednisone, and Bevacizumab to Treat Metastatic Prostate Cancer

This is a Phase II study of docetaxel, bevacizumab, prednisone and thalidomide in patients with androgen independent metastatic prostate cancer who are previously untreated with chemothera...

RAD001 Plus Bevacizumab in Metastatic Melanoma

This is a non-randomized, open label Phase II study. All patients will begin treatment with the same doses of RAD001 and bevacizumab. Patients will receive 6 weeks of treatment, followed...

PubMed Articles [14422 Associated PubMed Articles listed on BioPortfolio]

Pomegranate extract inhibits the bone metastatic growth of human prostate cancer cells and enhances the in vivo efficacy of docetaxel chemotherapy.

Docetaxel treatment is the only first-line chemotherapy with a survival benefit in metastatic castration-resistant prostate cancer (PCa). Nonetheless, most patients become docetaxel resistant and inev...

Enhanced anticancer activity of a combination of docetaxel and Aneustat (OMN54) in a patient-derived, advanced prostate cancer tissue xenograft model.

The current first-line treatment for advanced metastatic prostate cancer, i.e. docetaxel-based therapy, is only marginally effective. The aim of the present study was to determine whether such therapy...

Risk factors for febrile neutropenia in patients receiving docetaxel chemotherapy for castration-resistant prostate cancer.

Docetaxel is a standard therapy for patients with castration-resistant prostate cancer (CRPC). However, docetaxel-associated adverse events (AEs) such as febrile neutropenia (FN) can impair quality of...

Cardiac safety results from a phase II, open-label, multicenter, pilot study of two docetaxel-based regimens plus bevacizumab for the adjuvant treatment of subjects with node-positive or high-risk node-negative breast cancer.

Adding antiangiogenic therapy to standard chemotherapy has improved response rates and progression-free survival in metastatic breast cancer (BC) patients. This phase II study evaluated cardiac safety...

The Oncological Outcomes and Risk Stratification in Docetaxel Chemotherapy for Castration-resistant Prostate Cancer.

To clarify the risk factors and develop a refined risk-stratification model to help in the appropriate selection of docetaxel chemotherapy in patients with castration-resistant prostate cancer.

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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