Skip to content

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00093457
Enrollment
28
Registered
2004-10-08
Start date
2004-08-10
Completion date
2011-01-18
Last updated
2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate

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 patients who have metastatic or recurrent prostate cancer that has not responded to previous hormone therapy.

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.

Interventions

DRUGsorafenib tosylate

BAY 43-9006 given orally at 400 mg BID in a 28 day cycle

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
NCIC Clinical Trials Group
Lead SponsorNETWORK

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Prostate-specific antigen response and/or progression2 years

Secondary

MeasureTime frame
Objective response and/or progression2 years
Tolerability and toxicity2 years
Time to treatment failure and overall patient survival2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026