Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

NCT00512668 | Terminated Phase 1

• 2 other identifiers: NCI-2012-030982007-0025
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Safety, in terms of drug-related adverse events of two doses of temsirolimus following androgen ablation

  180 days

• Favorable and tolerable dose for prostate cancer patients who experience biochemical failure after prostatectomy and/or radiation therapy

  180 days

Study Arms (1)

Treatment (hormone therapy, temsirolimus)

EXPERIMENTAL

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.

Drug: leuprolide acetate; Drug: goserelin acetate; Drug: bicalutamide; Drug: nilutamide; Drug: flutamide; Drug: temsirolimus; Other: laboratory biomarker analysis

Interventions

leuprolide acetate DRUG

Given intramuscularly

Also known as: Enantone, LEUP, Lupron, Lupron Depot

Treatment (hormone therapy, temsirolimus)

goserelin acetate DRUG

Given subcutaneously

Also known as: ICI-118630, ZDX, Zoladex

Treatment (hormone therapy, temsirolimus)

bicalutamide DRUG

Given PO

Also known as: Casodex, CDX

Treatment (hormone therapy, temsirolimus)

nilutamide DRUG

Given PO

Also known as: ANAN, Anandron, Nilandron

Treatment (hormone therapy, temsirolimus)

flutamide DRUG

Given PO

Also known as: Eulexin, Eulexine, FLUT, Sch 13521

Treatment (hormone therapy, temsirolimus)

temsirolimus DRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel

Treatment (hormone therapy, temsirolimus)

laboratory biomarker analysis OTHER

Optional correlative studies

Treatment (hormone therapy, temsirolimus)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; Goserelin; bicalutamide; nilutamide; Flutamide; temsirolimus; Sirolimus

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Macrolides; Lactones

Study Officials

• Christopher Logothetis

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2008
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

US (1)