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Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer
This study has been completed.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00512668
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: flutamide
Drug: goserelin
Drug: leuprolide acetate
Drug: nilutamide
Drug: temsirolimus
Phase I

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Goserelin CCI 779 Leuprolide acetate Leuprolide Flutamide Bicalutamide Nilutamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: 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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety and drug-related adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Favorable and tolerable dose [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2007
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.
  • To select a favorable and tolerable dose for prostate cancer patients who experience biochemical failure after prostatectomy and/or radiotherapy.

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Biochemical relapse after local therapy (i.e., radical prostatectomy and/or definitive radiotherapy), as evidenced by rising serum PSA

    • PSA doubling time ≤ 12 months after local therapy, as determined by linear regression of all available PSA values within 6 months of initiation of androgen ablation

      • At least 1 PSA measurement ≥ 1.0 ng/mL for patients who underwent prostatectomy
      • At least 1 PSA measurement ≥ 3.0 ng/mL and ≥ 150% post-radiotherapy nadir for patients who underwent radiotherapy
  • No local recurrence
  • Androgen ablation initiated within the past 8 weeks
  • PSA < 40 ng/mL within the past 3 weeks
  • No evidence of metastasis as determined by bone scan or CT scan
  • Registered in the M.D. Anderson Cancer Center institutional database

Exclusion criteria:

  • Histologic variants other than adenocarcinoma in the primary tumor

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-2
  • Leukocytes ≥ 3,000/mm³
  • ANC ≥ 1,000/mm³
  • Hemoglobin ≥ 8.0 g/dL (transfusions allowed)
  • Platelet count > 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and/or ALT ≤ 3 times ULN
  • Creatinine ≤ 1.5 times ULN OR calculated creatinine clearance ≥ 60 mL/min
  • Serum cholesterol level < 350 mg/dL
  • Triglyceride level < 300 mg/dL
  • Must use effective contraception

Exclusion criteria:

  • Uncontrolled concurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection requiring parenteral therapy on day 1 of protocol treatment
    • Symptomatic congestive heart failure resulting in a resting O_² saturation < 92% on room air
    • Unstable angina pectoris
    • Myocardial infarction within the past 6 months
    • Ongoing maintenance therapy for life-threatening ventricular arrhythmia, known pulmonary hypertension, or pneumonitis
  • Severely compromised immunological state, including HIV positivity due to possible pharmacokinetic interactions with Highly Active Antiretroviral Therapy
  • Acute or chronic hepatitis B or C
  • History of any other cancer, except nonmelanoma skin cancer, unless in complete remission and off all therapy for that disease for a minimum of 3 years

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • See Disease Characteristics

Exclusion criteria:

  • Prior systemic treatment for prostate cancer

    • Androgen ablation therapy for ≤ 3 months in a neoadjuvant and/or adjuvant setting AND ≥ 1 year since last administration is allowed
  • Immunosuppressive agents, including intravenous corticosteroids, within 3 weeks of study entry
  • Other concurrent investigational agents
  • Concurrent immunotherapy or immunosuppressive therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512668

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Christopher Logothetis, MD M.D. Anderson Cancer Center
Investigator: Eleni Efstathiou M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000559627, MDA-2007-0025
Study First Received: August 6, 2007
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00512668  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Nilutamide
Leuprolide
Goserelin
Bicalutamide
Urogenital Neoplasms
Flutamide
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on January 15, 2009