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Status:

COMPLETED

Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

Lead Sponsor:

NCIC Clinical Trials Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Prostate Cancer

Eligibility:

MALE

18-120 years

Phase:

PHASE2

Brief Summary

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 patient...

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. Seco...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 10 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 18 2011

    Estimated Enrollment :

    28 Patients enrolled

    Trial Details

    Trial ID

    NCT00093457

    Start Date

    August 10 2004

    End Date

    January 18 2011

    Last Update

    August 4 2023

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, Canada, T2N 4N2

    2

    British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, Canada, V1Y 5L3

    3

    British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    4

    CancerCare Manitoba

    Winnipeg, Manitoba, Canada, R3E 0V9