Prostate Cancer Clinical Trial
Official title:
A Phase I/II Study of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer
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).
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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