Prostate Cancer Clinical Trial

Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must also have signed an authorization for the release of their protected health information
Patients must have histologically confirmed adenocarcinoma of the prostate recurring after local therapy (radical prostatectomy and/or radiation therapy) as evidenced by rising serum PSA
Prostate-Specific Antigen (PSA) Doubling Time (PSADT) =< 12 months after local therapy (prostatectomy and/or definitive radiation) as determined by linear regression of all available PSA values within 6 months of initiation of androgen ablation (for patients who underwent prostatectomy, at least one PSA measurement of >= 1.0 ng/mL; for patients who underwent radiation, at least one PSA measurement of >= 3.0 ng/mL and >= 150% postradiation nadir)
No evidence of metastasis as determined by bone scan or computed tomography (CT) scan
Initiation of Androgen Ablation of less than 8 weeks' duration prior to study entry is permitted
Leukocytes ≥ 3,000/mcl
Absolute neutrophil count ≥ 1,000/mcl

Hemoglobin ≥ 8.0g/dl

Eligibility level for hemoglobin may be reached by transfusion
Platelet count >= 100,000/μL
Total bilirubin ≤1.5 X laboratory ULN
AST and/or ALT ≤ 3 X laboratory ULN
Creatinine ≤ 1.5 X laboratory ULN OR calculated creatinine clearance ≥ 60 ml/min/1.73 m^2 for patients w/creatinine levels above the laboratory ULN
Serum cholesterol level < 350 mg/dl
Triglyceride level < 300mg/dl
ECOG performance status 0, 1 or 2
The effects of Temsirolimus on the developing human fetus are unknown; for this reason men must agree to use contraception from the time of study enrollment continuing for the duration of study participation
Patients must be registered in the MDACC institutional database prior to treatment with study drug
PSA < 40 ng/ml

Exclusion Criteria:

Patients with histologic variants other than adenocarcinoma in the primary tumor
Patients may not be receiving any other investigational agents
Patients may not be receiving concomitant immunotherapy or immunosuppressive therapy
Patients may not have received prior systemic treatment for prostate cancer (other than no more than 3 months of prior treatment with androgen ablation in neoadjuvant and/or adjuvant setting and at least a year must have elapsed since last administration) unless initiation of Androgen Ablation of less than 8 weeks' duration prior to study entry is permitted
Patient with uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring parenteral therapy on day 1 of protocol treatment, symptomatic congestive heart failure resulting in a resting O2 saturation of < 92% on room air, unstable angina pectoris, myocardial infarction within the previous 6 months, or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia, known pulmonary hypertension or pneumonitis
Patients in a severely compromised immunological state, including being positive for the human immunodeficiency virus (HIV) due to possible pharmacokinetic interactions with HAART therapy
Patients diagnosed with acute or chronic hepatitis B or C
Patients using immunosuppressive agents, including intravenous corticosteroids, within 3 weeks of study entry
Patients must not have a history of any other cancer (except nonmelanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT00512668

Recruitment Status:

Terminated

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT00512668

Recruitment Status:

Terminated

Sponsor:


National Cancer Institute (NCI)

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