RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer
Condition: Hormone Refractory Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: RAD001
Intervention description: RAD001 at a dose of 10 mg PO daily
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the biochemical response rate (PSA) to single agent
      RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of adenocarcinoma of the prostate

          -  Clinical or radiographic evidence of metastatic disease

          -  ADT using LHRH agonist (eg leuprolide, goserelin) must continue on therapy. However,
             ketoconazole, estrogens, and all other forms of hormonal manipulation are not
             permitted on study.

          -  Evidence of disease progression on ADT as evidenced by:

               -  2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and
                  separated at least 1 week apart, or

               -  Radiographic evidence of disease progression defined by RECIST criteria and
                  compared to prior studies on ADT.

          -  A minimum of 6 weeks has elapsed off of anti-androgen therapy without withdrawal
             response.

          -  A minimum of 4 weeks from any prior radiation therapy, surgery, chemotherapy or other
             investigational agent

          -  Biopsies will not be performed if platelet counts < 75,000/ ul, PTT, PT or INR > 1.4
             times control

          -  Patients must have normal organ and marrow function as defined below:

          -  hemoglobin > 9.0g/dL

          -  absolute neutrophil count > 1,500/μl

          -  platelets > 100,000/μl

          -  total bilirubin < 1.5 X upper limit of normal (ULN)

          -  AST(SGOT)/ALT(SGPT) < 2.5 X ULN

          -  creatinine < 1.5 X ULN

          -  total fasting cholesterol < 350

          -  total triglycerides < 300

          -  Patients on antilipid therapy may participate in this study.

          -  Age > 18 years

          -  ECOG performance status 0 or 1

          -  Ability to swallow and retain oral medication

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  History of solid organ or stem cell transplantation

          -  Also, no current use of chronic immunosuppressive therapy is allowed

          -  Patients with known brain metastases (or history of brain metastases)

          -  History of HIV, hepatitis B, or hepatitis C infection

          -  Patients who have received investigational, biologic, hormonal (other than ADT),
             immunotherapy, or chemotherapy less than 4 weeks prior to entry on this study or have
             not recovered from the toxic effects of such therapy

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection (requiring antifungal, antibiotic or antiviral therapy), symptomatic
             congestive heart failure (NYHC III or greater), unstable angina pectoris, cardiac
             arrhythmia (uncontrolled SVT or any VT), or psychiatric illness/social situations that
             would limit compliance with study requirements

          -  History of malabsorption syndrome, disease significantly affecting gastrointestinal
             function or major resection of the stomach or small bowel that could affect
             absorption, distribution, metabolism or excretion of study drugs.

          -  Any unresolved bowel obstruction or diarrhea