A Phase I/II Study of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer
- Patients will be designated into one of two groups based upon the results of a FDG-PET
- 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
- 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
Dose and toxicity of docetaxel and RAD001 in HRPC Response rate to docetaxol and RAD001 in HRPC
Mary Ellen Taplin, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Oregon Health Science University||Portland, Oregon 97239|