Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
BMS-275291 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
This study has been completed.
Sponsors and Collaborators: University of California, Davis
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00040755
  Purpose

RATIONALE: BMS-275291 may stop the growth of prostate cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Randomized phase II trial to study the effectiveness of BMS-275291 in treating patients who have prostate cancer that has not responded to hormone therapy.


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

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: BMS 275291
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Randomized Phase II Trial Of BMS-275291 (NSC 713763, IND 62573) In Hormone Refractory Prostate Cancer

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

Study Start Date: May 2002
Detailed Description:

OBJECTIVES:

  • Compare the time to disease progression in patients with hormone-refractory prostate cancer treated with two different doses of BMS-275291.
  • Determine the overall survival of patients treated with this drug.
  • Determine the rate of response, in terms of PSA and measurable disease, in patients treated with this drug.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Correlate tumor response with changes in the levels of serum osteocalcin, alkaline phosphatase, procollagen I carboxy-terminal propeptide, procollagen I amino-terminal propeptide, and N-telopeptide, and with changes in the levels of urine pyridinoline and deoxypyridinoline in patients treated with this drug.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score (2-4 vs 5-7 vs 8-10), PSA level (less than 10 ng/mL vs 10-50 ng/mL vs 51-100 ng/mL vs more than 100 ng/mL), and concurrent bisphosphonate therapy (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive oral BMS-275291 once daily on days 1-28.
  • Arm II: Patients receive oral BMS-275291 twice daily on days 1-28. In both arms, treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 24-68 patients (12-34 per treatment arm) will be accrued for this study within 5-14 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic disease

    • Bone metastases by x-ray, bone scan, MRI, or biopsy
  • Hormone-refractory disease (despite androgen deprivation and antiandrogen withdrawal if applicable) defined by at least 1 of the following criteria:

    • Progression of unidimensionally measurable disease within the past 28 days
    • Progression of evaluable but not measurable disease within the past 28 days
    • At least 2 consecutive increases in PSA taken at least 1 week apart
  • Measurable or non-measurable disease

    • Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
    • Soft tissue disease that has been irradiated 2 or more months prior to study is considered measurable disease if the lesion progressed after radiation
    • Must have at least 1 measurable lesion outside previously irradiated area to be considered measurable disease
  • Must have been surgically or medically castrated
  • No prior or concurrent, treated or untreated brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST and ALT no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Other:

  • Fertile patients must use effective contraception during and for 3 months after study
  • Recovered from prior major infections
  • No other significant active concurrent medical illness that would preclude study
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of any site, or other adequately treated stage I or II cancer that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biological response modifiers

Chemotherapy:

  • No more than 1 prior chemotherapy regimen
  • At least 3 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide or ketoconazole
  • At least 6 weeks since prior bicalutamide or nilutamide
  • Must continue any luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide or goserelin) started prior to study
  • No concurrent corticosteroid or hormonal therapy (except LHRH agonist therapy)

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • At least 3 months since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium and recovered
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from any prior surgical procedures

Other:

  • No concurrent bisphosphonates unless therapy began prior to study
  • No concurrent unconventional therapy for malignancy (e.g., St. John's Wort, PC-SPES, or other herbal remedies)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040755

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
LaGrange Memorial Hospital
LaGrange, Illinois, United States, 60525
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Michigan
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, United States, 49085
Sponsors and Collaborators
University of California, Davis
Investigators
Study Chair: Primo N. Lara, MD University of California, Davis
  More Information

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

Publications of Results:
Study ID Numbers: CDR0000069402, UCD-CHNMC-PHII-32, CHNMC-PHII-32, NCI-5615
Study First Received: July 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00040755  
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:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009