NCT00512668

Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of temsirolimus when given together with hormone therapy in treating patients with relapsed prostate cancer. Androgens can cause the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by lowering the amount of androgens the body makes. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hormone therapy together with temsirolimus may kill more tumor cells

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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). OUTLINE: 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 unacceptable toxicity. 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.

Conditions

• Adenocarcinoma of the Prostate
• Recurrent Prostate Cancer

Interventions

Type	Name	Description
DRUG	leuprolide acetate	Given intramuscularly
DRUG	goserelin acetate	Given subcutaneously
DRUG	bicalutamide	Given PO
DRUG	nilutamide	Given PO
DRUG	flutamide	Given PO
DRUG	temsirolimus	Given IV
OTHER	laboratory biomarker analysis	Optional correlative studies

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-01-01
• First posted: 2007-08-08
• Last updated: 2013-01-07

Locations

1 site across 1 country: United States