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Sponsors and Collaborators: |
Cedars-Sinai Medical Center Novartis Genentech |
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Information provided by: | Cedars-Sinai Medical Center |
ClinicalTrials.gov Identifier: | NCT00574769 |
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).
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: RAD001, Docetaxel, Bevacizumab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase Ib/II Evaluation of RAD001 With Docetaxel and Bevacizumab in Patients With Metastatic Androgen Independent Prostate Cancer |
Estimated Enrollment: | 42 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | January 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: RAD001, Docetaxel, Bevacizumab
RAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily Bevacizumab infusion (IV), 15 mg/kg every 21 days Docetaxel infusion (IV), 75 mg/m^2 every 21 days |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required Initial Laboratory Values:
Exclusion Criteria:
Contact: Koo Nguyen, BS | 310-423-7600 | koo.nguyen@cshs.org |
Contact: Tina Tolbert, BA | 310-423-7600 | tina.tolbert@cshs.org |
United States, California | |
Louis Warschaw Prostate Cancer Center at Cedars Sinai Medical Center | Recruiting |
Los Angeles, California, United States, 90048 |
Principal Investigator: | Mitchell E Gross, MD, Ph.D | Cedars-Sinai Medical Center |
Responsible Party: | Cedars-Sinai Medical Center ( Mitchell Gross, MD, Ph.D ) |
Study ID Numbers: | 10405, AVF3955s, CRAD001CUS2468 |
Study First Received: | December 14, 2007 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00574769 |
Health Authority: | United States: Food and Drug Administration |
RAD001 mTOR inhibition docetaxel bevacizumab adenocarcinoma of the prostate |
recurrent prostate cancer stage IV prostate cancer prostate cancer Metastatic, androgen independent prostate cancer |
Everolimus Docetaxel Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Bevacizumab Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Immunologic Factors Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions |