Conditions: Metastatic, Androgen Independent Prostate Cancer Prostate Cancer
Keywords: prostate cancer RAD001 mTOR inhibition docetaxel
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 19
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I).

Once an appropriate dose is reached, the purpose then will be to determine the response rate of docetaxel plus RAD001 (Phase II).

Detailed description:
* Patients will be designated into one of two groups based upon the results of a FDG-PET scan.
* A patient with a baseline positive scan will have serum drawn for baseline serum proteomics assessment then be treated with RAD001 daily for two weeks. On day 10-14, another FDG-PET scan and serum assessment will be performed. An optional bone marrow biopsy may also be done. On day 15, patients will enter the Phase I portion of the trial at the current enrolling dosage or if Phase I is completed patients will enter Phase II.
* A patient that does not have a positive scan will enter directly into the Phase I trial or Phase II depending on which trial is currently enrolling.
* Phase I trial patients will have weekly laboratory evaluations and clinical evaluation every three weeks.
* Phase II trial patients will have laboratory evaluations on day one and day eight and clinical evaluation every three weeks.
* The maximum duration of the trial is one year of therapy.

Arms:
arm 1: RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.

Interventions: intervention 1: RAD001 intervention 2: Docetaxel intervention 3: Prednisone
Intervention descriptions: intervention 1: Daily for two weeks intervention 2: Infusion once per cycle intervention 3: Prednisone 5 mg by mouth twice daily

Protocol document: