Title A Phase I Study of the mTOR Inhibitor Temsirolimus in Combination with the HDAC Inhibitor Vorinostat in Patients with Metastatic Prostate Cancer
Principal Investigator Roberto Pili, MD
Study Number 150709
Summary This is a Phase I research study. "Phase I" means that the combination of the study drugs is either being studied for the first time in humans or has been tested a limited number of times in humans. In this Phase I study we will start at the low doses of vorinostat and temsirolimus and slowly increase the amount of drugs that is given to the study subjects until the side effects of the combination are too high. This means that not all people in the study will get the same doses of vorinostat and temsirolimus. Doses at the beginning of the study will be lower than doses at the end of the study. Because of the design of the study, some people will probably get doses that are too low to have an effect, and other people will probably get doses that cause side effects.
- Patients must have a histologically confirmed diagnosis of adenocarcinoma of the prostate, carcinoma that is hormone refractory and with evidence of progressive metastatic disease following docetaxel treatment by any of the following:
- Increased serum prostate-specific antigen (PSA) levels confirmed by 3 consecutive PSA measurements, the first sample to be taken at least 6 weeks after bicalutamide or megestrol acetate withdrawal.
- Progression of bidimensionally measurable soft tissue (nodal) metastasis by CT scan or MRI within the past 4 weeks
- Progression of bone disease by new bone lesions on bone scan within the past 6 weeks
- Patients should be without persisting toxicities of previous treatment that would preclude evaluation of toxic effects of study treatment
- Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been radiated
- Castrate levels of serum testosterone confirmed within two weeks prior to Day 1 treatment. Testosterone levels will be required for patients who have had bilateral orchiectomy
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy and are considered by their physician to be at less than 30% risk of relapse.