Phase Ib Study of Limited Androgen Ablation and Two Dose Levels of Temsirolimus (NSC#683864) in Patients With Prostate Cancer Who Have a Biochemical Relapse After Prostatectomy and/or Radiotherapy
I. To characterize safety and drug-related adverse events of two doses (15 and 25 mg) of
intravenous weekly temsirolimus combined with short term complete androgen ablation and to
select a favorable and tolerable dose for prostate cancer patients who experience
biochemical failure after prostatectomy and/or radiation therapy.
I. To archive tissue and blood components for future study of molecular markers of response
and disease progression.
II. To evaluate the effects of 2 dose levels of temsirolimus on changes in the
phosphorylation state of proteins in the mTOR pathway using western blots on peripheral
blood mononuclear cells (PBMCs).
Patients receive combined androgen ablation therapy comprising a luteinizing
hormone-releasing hormone analogue (i.e., leuprolide acetate intramuscularly once monthly or
goserelin subcutaneously every 3 months) and an oral anti-androgen drug (i.e., bicalutamide
or nilutamide once daily or flutamide 3 times daily) on days 1-90.* Beginning on day 60 of
hormonal therapy, patients receive temsirolimus IV over 30 minutes once weekly. Treatment
with temsirolimus continues for up to 36 weeks in the absence of disease progression or
NOTE: *Patients may receive no more than 3 months of hormonal therapy, including therapy
initiated within 2 months of study entry.
After completion of study therapy, patients are followed at 30 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety, in terms of drug-related adverse events of two doses of temsirolimus following androgen ablation
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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