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
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.
Interventional
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
3 years
Yes
Mary Ellen Taplin, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
05-184
NCT00459186
November 2005
December 2012
Name | Location |
---|---|
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 |