Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Alternate Title

Prednisone With or Without BMS-182751 in Treating Patients With Advanced Prostate Cancer That Is Refractory to Hormone Therapy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Over 18 EORTC-30972 BMS-CA142-025

Objectives

I.   Compare the overall survival and time to pain progression of patients 
receiving prednisone alone or in combination with BMS-182751 in patients with 
hormone refractory prostate cancer who have not been previously treated with 
chemotherapy.

II.  Compare pain response rates, safety, time to overall progression, and 
quality of life in these patients.

Entry Criteria

Disease Characteristics:

Pathologically or cytologically diagnosed, advanced, hormone refractory
adenocarcinoma of the prostate

Documented progression of disease (i.e., worsening disease-related pain,
increasing PSA, new painful bone lesions, increase in measurable disease)

No known history of brain metastases

Pain score 0-3

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior/concurrent chemotherapy

Endocrine therapy:
 Prior antiandrogens, estrogens, and LHRH agonists allowed to achieve castrate
  status
 At least 4 weeks since prior antiandrogen therapy
 No prior corticosteroids

Radiotherapy:
 Prior radiotherapy to less than 30% of marrow and recovered
 No prior large field radiotherapy
 No prior strontium-89

Surgery:
 Prior orchiectomy allowed to achieve castrate status

Other:
 At least 30 days since prior investigational agents
 No other concurrent investigational agents
 Stable analgesic regimen required for at least 1 week prior to study in
  patients with disease-related pain

Patient Characteristics:

Age:
 Over 18

Performance status:
 WHO 0-2

Life expectancy:
 Greater than 3 months

Hematopoietic:
 WBC at least 3,000/mm3
 Absolute neutrophil count at least 2,000/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Bilirubin no greater than 1.5 times upper limit of normal (ULN)
 AST/ALT no greater than 2 times ULN

Renal:
 Creatinine within institutional normal range
 Creatinine clearance at least 60 mL/min

Other:
 Must be able to swallow pills
 No history of prior malignancy except basal or squamous cell skin cancer
 No concurrent uncontrolled medical disorder
 No history of major gastrointestinal surgery or pathology likely to influence
  absorption
 No active peptic ulcer disease
 No active diabetes mellitus

Expected Enrollment

This study will accrue 380 patients in 3 years.

Outline

This is a randomized, multicenter, open label study.  Patients are randomized 
to receive prednisone alone or in combination with BMS-182751.  Patients are 
stratified by institution, presence or absence of disease-related pain, and 
presence or absence of clinically detectable disease.

Arm I:  Patients receive prednisone by mouth twice daily with food for 35 
days.  BMS-182751 is administered by mouth once daily (AM) for 5 days.

Arm II:  Patients receive prednisone by mouth twice daily with food for 35 
days.

Courses repeat every 35 days.  Patients may continue BMS-182751 for a maximum 
of 8 courses in the absence of toxicity and disease progression.  Patients may 
be treated with prednisone continuously in the absence of toxicity and disease 
progression.

Patients are followed every 3 months until death.

Sternberg CN, Whelan P, Hetherington J, et al.: Phase III trial of satraplatin, an oral platinum plus prednisone vs. prednisone alone in patients with hormone-refractory prostate cancer. Oncology 68 (1): 2-9, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Cora Sternberg, MD, FACP, Protocol chair(Contact information may not be current)		Ph: 39-2-2643-2754