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

Alternate Title

Sorafenib in Treating Patients With Metastatic Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCI-04-C-0262 NCI-6594, 6594, NCT00093431

Special Category: NCI Web site featured trial

Objectives

1. Determine whether sorafenib is associated with a 50% 4-month probability of progression-free survival, in terms of clinical, radiographic, and prostate-specific antigen (PSA) criteria, in patients with metastatic androgen-independent prostate cancer.

Secondary

1. Determine the time to progression, in terms of clinical and radiographic criteria, in patients treated with this drug.
2. Determine the biochemical effects of this drug by biopsy of these patients' tissues.
3. Determine overall response rate and overall survival in patients treated with this drug.
4. Determine the pharmacokinetics of this drug in these patients.
5. Determine the PSA response rate in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically confirmed prostate cancer
  • Metastatic disease



• Progressive androgen-independent disease
  • Radiographical evidence of disease progression after primary surgery or radiotherapy that continues to progress despite hormonal agents
  • Progression is defined by meeting at least 1 of the following criteria:
    • Expanding measurable lesion
    • Appearance of new lesions
    • Increasing prostate-specific antigen levels on successive measurements
  • Patients treated with antiandrogens must have disease progression at least 4 weeks after withdrawal of flutamide or at least 6 weeks after withdrawal of bicalutamide or nilutamide



• Concurrent gonadotropin-releasing hormone agonists required for patients who have not undergone bilateral surgical castration



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• Concurrent hematopoietic growth factor support (e.g., epoetin alfa or darbepoetin alfa) allowed

Chemotherapy

• No more than 1 prior cytotoxic chemotherapeutic line (i.e., cytotoxic agents received in more than 1 way allowed)
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin; 3 months for suramin)

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics
• More than 4 weeks since prior radiotherapy (including radioisotopes)

Surgery

• See Disease Characteristics

Other

• Recovered from all prior therapy
• Concurrent bisphosphonates for known bone metastases allowed
• Concurrent nonsteroidal anti-inflammatory drugs allowed
• Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed provided all of the following criteria are met:
  • PT < 1.1 times upper limit of normal (ULN)
  • INR < 1.1
  • PTT normal
• No concurrent verapamil or diltiazem
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer therapy
• No other concurrent investigational agents

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• No history of bleeding diathesis

Hepatic

• AST and ALT ≤ 2.5 times ULN
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

  OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No uncontrolled hypertension, defined as systolic blood pressure (BP) > 170 mm Hg OR diastolic BP > 100 mm Hg
  • Hypertension controlled by medication allowed
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Fertile patients must use effective contraception
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
• No active or ongoing infection
• No psychiatric illness or social situation that would preclude study compliance
• No other malignancy within the past 2 years except nonmelanoma skin cancer or noninvasive bladder cancer
• No other uncontrolled illness

Expected Enrollment

A total of 22-46 patients will be accrued for this study within 1.5 years.

Outcomes

Progression-free survival at 4 months by clinical, radiographic, and prostate-specific antigen (PSA) criteria

Proteomics
PSA
Pharmacokinetics
Molecular effects

Outline

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Aragon-Ching JB, Jain L, Gulley JL, et al.: Final analysis of a phase II trial using sorafenib for metastatic castration-resistant prostate cancer. BJU Int 103 (12): 1636-40, 2009.[PUBMED Abstract]

Dahut WL, Scripture C, Posadas E, et al.: A phase II clinical trial of sorafenib in androgen-independent prostate cancer. Clin Cancer Res 14 (1): 209-14, 2008.[PUBMED Abstract]

Posadas EM, Gulley J, Arlen PM, et al.: A phase II study of BAY 43-9006 in patients with androgen-independent prostate cancer (AIPC) with proteomic profiling. [Abstract] J Clin Oncol 23 (Suppl 16): A-4762, 443s, 2005.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

William Dahut, MD, Principal investigator		Ph: 301-435-8183 Email: dahutw@mail.nih.gov

Related Information

Featured trial article
Web site for additional information

Registry Information
Official Title		A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer
Trial Start Date		2004-09-27
Trial Completion Date		2009-04-14
Registered in ClinicalTrials.gov		NCT00093431
Date Submitted to PDQ		2004-08-13
Information Last Verified		2009-01-07

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