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Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: June 6, 2002   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039104
  Purpose

RATIONALE: Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Combining zoledronate with BMS-275291 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in treating patients who have prostate cancer that has not responded to previous hormone therapy.


Condition Intervention Phase
Prostate Cancer
Drug: BMS-275291
Drug: zoledronic acid
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Zoledronic acid BMS 275291
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II, Open-Label, Randomized Trial Of Zoledronic Acid (Zometa) And BMS-275291 (NSC#713763) In Patients With Hormone Refractory Prostate Cancer

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

Study Start Date: April 2002
Detailed Description:

OBJECTIVES:

  • Compare the confirmed response rate of patients with hormone-refractory prostate cancer treated with zoledronate and BMS-275291.
  • Compare the toxicity profile of these regimens in these patients.
  • Compare the overall and progression-free survival of patients treated with these regimens.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and participating center.

  • Arm I : Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28.
  • Arm II (closed to accrual as of 10/10/2003): Patients receive zoledronate as in arm I.

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 21 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate

    • Refractory to hormonal therapy
  • Metastatic bone disease documented by bone scan and confirmed by x-rays, CT scan, or MRI

    • Patients may also have measurable disease in retroperitoneal, pelvic, or inguinal lymph nodes or the prostate and/or prostatic bed
  • Prostate-specific antigen (PSA) progression

    • Two consecutive increases in PSA values

      • Measurements taken at least 1 week apart and at least 4 weeks since prior flutamide, nilutamide, or megestrol-based agent (8 weeks for bicalutamide)
  • PSA at least 5 ng/mL
  • Testosterone less than 50 ng/dL within the past 3 months
  • Treatment with one of the following:

    • Continuing primary androgen suppression with luteinizing hormone-releasing hormone agonist
    • Prior orchiectomy
  • No known CNS metastases
  • No known visceral metastases (e.g., pulmonary, liver, kidney, or splenic lesions)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 6 months

Hematopoietic:

  • WBC at least 2,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 1.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • Fertile patients must use effective contraception
  • No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma, or other cancer from which patient has been disease free for at least 5 years
  • No other uncontrolled concurrent illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No more than 1 prior non-hormonal treatment for metastatic disease, including biologic therapy, gene therapy, and antiangiogenesis therapy
  • At least 4 weeks since prior biologic therapy or immunotherapy

Chemotherapy:

  • No more than 2 prior chemotherapy regimens

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent steroids
  • No concurrent hormonal agents except luteinizing hormone-releasing hormone

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No prior systemic radiopharmaceuticals (e.g., samarium Sm 153 lexidronam pentasodium and strontium chloride Sr 89)
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent anticancer agents
  • Recovered from all prior therapy
  • At least 4 weeks since prior PC-SPES
  • Prior bisphosphonates allowed
  • No prior matrix metalloproteinase inhibitors
  • No other concurrent investigational therapy or supportive care
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039104

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Roberto Pili, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069352, MAYO-MC0151, NCI-5361
Study First Received: June 6, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00039104     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Zoledronic acid
Prostatic Diseases
Genital Neoplasms, Male
Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Hormones
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Zoledronic acid
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Physiological Effects of Drugs
Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009