Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093457
Recruitment Status : Completed
First Posted : October 8, 2004
Last Update Posted : September 28, 2011
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

October 6, 2004
October 8, 2004
September 28, 2011
July 2004
September 2006   (Final data collection date for primary outcome measure)
Prostate-specific antigen response and/or progression [ Time Frame: 2 years ]
Not Provided
Complete list of historical versions of study NCT00093457 on Archive Site
  • Objective response and/or progression [ Time Frame: 2 years ]
  • Tolerability and toxicity [ Time Frame: 2 years ]
  • Time to treatment failure and overall patient survival [ Time Frame: 2 years ]
Not Provided
Not Provided
Not Provided
Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer
A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying the effectiveness of sorafenib in treating patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.


  • Determine the efficacy of sorafenib, as measured by prostate-specific antigen response, in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the prostate.


  • Determine the objective response rate and duration of response in patients treated with this drug.
  • Determine the tolerability and toxicity of this drug in these patients.
  • Determine time to treatment failure and overall survival in patients treated with this drug.
  • Explore the relationship between measures of ras/raf pathway activation (pERK) and response to treatment in these patients.

OUTLINE: This is a non-randomized, multicenter study.

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

Patients are followed at 4 weeks after going off study treatment and then periodically for survival. Patients with stable or responding disease, when they go off study treatment, are followed every 3 months until relapse or progression.

PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study within 12-18 months.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: sorafenib tosylate
BAY 43-9006 given orally at 400 mg BID in a 28 day cycle
Not Provided
Chi KN, Ellard SL, Hotte SJ, Czaykowski P, Moore M, Ruether JD, Schell AJ, Taylor S, Hansen C, Gauthier I, Walsh W, Seymour L. A phase II study of sorafenib in patients with chemo-naive castration-resistant prostate cancer. Ann Oncol. 2008 Apr;19(4):746-51. Epub 2007 Dec 3.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
January 2011
September 2006   (Final data collection date for primary outcome measure)


  • Histologically confirmed adenocarcinoma of the prostate

    • Metastatic or recurrent disease
  • No curative standard therapy exists
  • Hormone-refractory disease

    • Evidence of prostate-specific antigen (PSA) progression during androgen ablation therapy, including medical or surgical castration

      • Documented PSA progression after completion of prior peripheral anti-androgens

        • At least a 25% increase (≥ 5 ng/mL) over a reference value PSA with 2 consecutive rising PSAs taken ≥ 1 week apart
      • Castrate level of testosterone ≤ 1.7 nmol/L for patients on medical androgen ablation

        • Patients receiving luteinizing hormone-releasing hormone agonist therapy must continue this treatment during study participation
  • PSA ≥ 10 ng/mL at the time of study entry
  • Primary tumor tissue (paraffin embedded) must be available for immunohistochemistry
  • Minimal symptomatic disease

    • No requirement for morphine or equivalent dose > 30 mg/day to control pain
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 weeks


  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No evidence of bleeding diathesis


  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal


  • Serum creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina
  • No active cardiomyopathy
  • No unstable ventricular arrhythmia
  • No uncontrolled hypertension


  • No serious infection
  • No active peptic ulcer disease
  • No upper gastrointestinal or other condition that would preclude study compliance with oral medication
  • No uncontrolled psychotic disorder
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib or other study agents
  • No other serious illness or medical condition that would preclude study participation
  • No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or other curatively treated solid tumor


Biologic therapy

  • Concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other growth factors allowed for the management of adverse events only


  • No prior chemotherapy
  • No other prior cytotoxic chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • Concurrent steroids allowed provided there has been no increase in steroid requirements within the past 4 weeks AND no increase in dose is planned


  • At least 4 weeks since prior external-beam radiotherapy except low-dose non-myelosuppressive radiotherapy
  • Concurrent low-dose non-myelosuppressive palliative radiotherapy allowed


  • Not specified


  • No prior investigational anticancer agents
  • No concurrent therapeutic anticoagulation

    • Concurrent prophylactic low-dose warfarin for venous or arterial access devices allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  • No other concurrent investigational therapy
  • No concurrent grapefruit juice
  • Concurrent bisphosphonates allowed
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
CDR0000387987 ( Other Identifier: PDQ )
Not Provided
Not Provided
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )
NCIC Clinical Trials Group
National Cancer Institute (NCI)
Study Chair: Kim N. Chi, MD British Columbia Cancer Agency
Canadian Cancer Trials Group
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP