A Study to Test the Safety & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer
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)
Links
- Source: http://clinicaltrials.gov/show/NCT00574769
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Prostate-specific Antigen
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.
Fenretinide
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.
Ultrasound, High-intensity Focused, Transrectal
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).
Prostatic Secretory Proteins
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.
Prostatic Neoplasms
Tumors or cancer of the PROSTATE.
Clinical Trials
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...
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from divi...
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
BACKGROUND:: The use of docetaxel prolongs survival for patients with castrate-resistant prostate cancer (CRPC). Inhibition of vascular endothelial growth factor (VEGF) with bevacizumab may further en...
Nasal septum perforation: a side effect of bevacizumab chemotherapy in breast cancer patients.
Background:Bevacizumab is an anti-vascular endothelial growth factor approved in association with paclitaxel or docetaxel as first line in patients (pts) with metastatic breast cancer. Rare cases of n...
To analyze the combined impact of the histone deacetylase (HDAC) inhibitor valproic acid (VPA) and the mammalian target of rapamycin (mTOR) inhibitor RAD001 on prostate cancer cell growth.
Chemotherapy-based treatment for castration-resistant prostate cancer.
Most men with metastatic prostate cancer respond to various types of androgen ablation but progress to castration-resistant disease. The TAX 327 and Southwest Oncology Group (SWOG) 99-16 clinical tria...
Docetaxel (Taxotere®) is a well established anti-mitotic chemotherapy agent. Among other therapeutic indications, docetaxel plus prednisone is indicated for first-line chemotherapy in patients with c...
