Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00093457
First received: October 6, 2004
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: sorafenib tosylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Prostate-specific antigen response and/or progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response and/or progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Tolerability and toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Time to treatment failure and overall patient survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: July 2004
Study Completion Date: January 2011
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sorafenib tosylate
    BAY 43-9006 given orally at 400 mg BID in a 28 day cycle
Detailed Description:

OBJECTIVES:

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

Secondary

  • 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.

  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 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 weeks

Hematopoietic

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

Hepatic

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

Renal

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

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • Not specified

Other

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093457

Locations
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Kim N. Chi, MD British Columbia Cancer Agency
  More Information

Additional Information:
Publications:
Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00093457     History of Changes
Other Study ID Numbers: I167, CAN-NCIC-IND167, CDR0000387987
Study First Received: October 6, 2004
Last Updated: September 27, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by NCIC Clinical Trials Group:
recurrent prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014