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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00526591 |
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This randomized phase II trial is studying the side effects and how well everolimus works in treating patients with newly diagnosed localized prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: everolimus Procedure: conventional surgery Procedure: diagnostic procedure Procedure: enzyme inhibitor therapy Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Phase II Study of Two Different Doses of RAD-001 (Everolimus) as Neo-Adjuvant Therapy in Patients With Localized Prostate Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Within 7 days after the last dose of everolimus, all patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy.
Tumor biopsy specimens acquired prior to treatment and prostate tumor tissue acquired at the time of radical prostatectomy are evaluated for biomarker correlative studies. Tissue samples are assessed by immunohistochemistry (IHC) and tissue microarray analysis for expression of cellular and molecular biomarkers (i.e., p-S6, p-4E-BP1, and p-Akt) that correlate with response. Prostatectomy specimens are also assessed by pathologic analysis for histopathologic response (i.e., pathologic stage, Gleason score, margin status, and tumor size).
After completion of study therapy, patients are followed at 6 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed newly diagnosed, localized adenocarcinoma of the prostate, meeting any of the following criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Gastrointestinal (GI) disease, condition, or symptoms that may significantly impair GI function and alter the absorption of everolimus, including any of the following:
Uncontrolled concurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 |
Study Chair: | Jorge A. Garcia, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000564323, CASE-21806, CASE-21806-CC256, NOVARTIS-CASE-21806 |
Study First Received: | September 5, 2007 |
Last Updated: | March 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00526591 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer |
Everolimus Oxymetazoline Immunologic Factors Prostatic Diseases Genital Neoplasms, Male Phenylephrine |
Adjuvants, Immunologic Urogenital Neoplasms Genital Diseases, Male Adenocarcinoma Immunosuppressive Agents Prostatic Neoplasms |
Everolimus Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Urogenital Neoplasms |
Enzyme Inhibitors Genital Diseases, Male Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Prostatic Neoplasms |