RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer

Daniel George, MD

Status and phase

Completed

Phase 2

Conditions

Hormone Refractory Prostate Cancer

Treatments

Drug: RAD001

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00629525

Pro00009495

7521 (Other Identifier)

Details and patient eligibility

About

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).

Full description

This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4 weeks. FLT-PET scans are performed at screening and again at day 28, following initiation of treatment in the first 10 patients. Patients are assessed for adverse events every two weeks for the first month and monthly thereafter. Patients are assessed for response by PSA every 4 weeks and when applicable, for objective response every 2 months. If 4 or more responses are seen in the first 39 patients then the study will expand to 60 patients.

Enrollment

35 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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