Efficacy and Safety Study of a New Leuprolide Acetate 17 mg Depot to Treat Prostate Cancer Patients

This study has been terminated.
Sponsor:
Information provided by:
GP-Pharm
ClinicalTrials.gov Identifier:
NCT00630799
First received: February 27, 2008
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

This is a multi-center, open-label study of 2 doses of leuprolide acetate 17 mg depot, administered three months apart, in subjects with prostate cancer who might benefit from medical androgen deprivation therapy


Condition Intervention Phase
Prostate Cancer
Drug: leuprolide acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of a New Leuprolide Acetate 17 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by GP-Pharm:

Primary Outcome Measures:
  • Percent of successful patients achieving chemical castration [ Time Frame: Days 28, 84, and 168 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WHO/ECOG performance status [ Time Frame: Days 14, 28, 56, 84, 112, and 168 ] [ Designated as safety issue: No ]
  • Serum LH concentration (mIU/mL) [ Time Frame: Days 2, 14, 28, 56, 84, 86, 112, and 168 ] [ Designated as safety issue: No ]
  • Serum FSH concentration (mIU/mL) [ Time Frame: Days 2, 14, 28, 56, 84, 86, 112, and 168 ] [ Designated as safety issue: No ]
  • Serum PSA concentration (ng/mL) [ Time Frame: Days 2, 14, 28, 56, 84, 86, 112, and 168 ] [ Designated as safety issue: No ]
  • Frequency of bone pain [ Time Frame: Days 2, 14, 28, 56, 54, 84, 86, 112, and 168 ] [ Designated as safety issue: No ]
  • plasma testosterone concentration (ng/mL) in PK population [ Time Frame: week 4 and week 12 ] [ Designated as safety issue: No ]
  • Occurrence of hot flushes [ Time Frame: Days 0, 2, 14, 28, 56, 84, 86, 112, and 168 ] [ Designated as safety issue: No ]
  • Plasma leuprolide concentrations (pg/mL) in PK population [ Time Frame: Days 2, 14, 28, 56, 84, 86, 112, and 168 ] [ Designated as safety issue: No ]
  • Frequency of urinary symptoms [ Time Frame: Days 2, 14, 28, 56, 54, 84, 86, 112, and 168 ] [ Designated as safety issue: No ]
  • Frequency of urinary pain [ Time Frame: Days 2, 14, 28, 56, 54, 84, 86, 112, and 168 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: May 2008
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
leuprolide acetate administered by i.m. injection as two doses of 17 mg each during a period of 6 months (one dose every 3 months)
Drug: leuprolide acetate
17 mg i.m.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males 18 years of age, with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy;
  • life expectancy of at least 1 year;
  • WHO/ECOG performance status of 0, 1, or 2;
  • adequate renal function at screening as defined by serum creatinine <= 1.6 times the upper limit of normal (ULN) for the clinical laboratory;
  • adequate and stable hepatic function as defined by bilirubin <= 1.5 times the ULN and transaminases (i.e. SGOT, SGPT) <= 2.5 times the ULN for the clinical laboratory at screening;
  • ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study;
  • signed written informed consent prior to inclusion in the study.

Exclusion Criteria:

  • Evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms;
  • evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms;
  • evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms;
  • presence of any tumor in the immediate vicinity which could cause cord compression, in the opinion of the Investigator, taking into account medical history and clinical observations;
  • excruciating, severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms;
  • testosterone levels <= 1.5 ng/mL at screening, locally determined at the laboratory of each clinical site;
  • previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g. antibody therapies, tumor-vaccines), biological response modifiers (e.g. cytokines) within 3 months of baseline;
  • previous hormonal therapy for treatment of prostate cancer, such as LHRH analogues (e.g. Lupron®, Zoladex®, etc.) (no wash-out allowed);
  • previous treatment with AR-receptor blockers, such as Casodex®, Fugerel®, Megace®, Androcur®(no wash-out allowed);
  • previous orchiectomy, adrenalectomy or hypophysectomy;
  • previous prostatic surgery (e.g. radical prostatectomy, transurethral resection of the prostate (TUR-P) within 2 weeks prior to or after baseline;
  • previous local therapy to the primary tumor with a curative attempt other than surgery (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy) within 2 weeks prior to or after baseline;
  • any investigational drug within 5 half-lives of its physiological action or 3 months, whichever is longer, before baseline;
  • administration of 5-α-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 3 months before baseline;
  • over-the-counter (OTC) or alternative medical therapies which have an estrogenic or anti-androgenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza®, Urinozinc®, DHEA) within the 3 months before baseline;
  • hematological parameters (RBC, total and differential WBC count, platelet count, hemoglobin, hematocrit) outside 20% of the upper or lower limits of normal (ULN, LLN) for the clinical laboratory at screening;
  • co-existent malignancy, according to the Investigator's opinion;
  • uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft) or significant symptomatic cardiovascular disease(s) within 6 months before baseline; resting uncontrolled hypertension: >=160/100 mmHg) or symptomatic hypotension within 3 months before baseline;
  • venous thrombosis within 6 months of baseline;
  • uncontrolled diabetes (patients with uncontrolled diabetes need to compensate the metabolic disorder before treatment with LH-RH analogues);
  • history of drug and/or alcohol abuse within 6 months of baseline;
  • serious concomitant illness(es) or disease(s) (e.g., hematological, renal, hepatic, respiratory, endocrine, psychiatric) that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol;
  • patients on anticoagulative therapy including warfarin (Coumadin®) and heparin. Those patients on low dose low molecular weight heparin may be enrolled in the study;
  • Abnormal coagulation studies (PT/PTT) at baseline.
  • blood donations/losses within 2 months of baseline, apart from previous prostatic surgery patients (see exclusion 10);
  • known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any excipients of the study formulation;
  • history of the following prior to the study:

    • immunization (within 4 weeks of baseline);
    • flu shots (within 1 week of baseline or 1 week prior to and after study drug administration);
    • anaphylaxis;
    • skin disease which would interfere with injection site evaluation;
    • dermatographism will be documented at screening and followed up while on treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630799

Locations
United States, Florida
Advanced Research Institute
New Port Richey, Florida, United States, 34655
United States, New Jersey
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
United States, New York
Hudson Valley Urology
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Center for Urologic Care
Bryn Mawr, Pennsylvania, United States, 19010
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Urology Associates
Nashville, Tennessee, United States, 37209
United States, Texas
Urology San Antonio Research, PA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
GP-Pharm
  More Information

No publications provided

Responsible Party: Claudio Savulsky/Director, Global Medical Affairs, GP Pharm S.A.
ClinicalTrials.gov Identifier: NCT00630799     History of Changes
Other Study ID Numbers: GP/C/04/PRO
Study First Received: February 27, 2008
Last Updated: September 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GP-Pharm:
prostate
cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 19, 2014