Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093457
• Other study ID #: I167
• Secondary ID: CAN-NCIC-IND167C
• Status: Completed
• Phase: Phase 2
• Start date: August 10, 2004
• Est. completion date: January 18, 2011

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 18, 2011
• Est. primary completion date: September 28, 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• sorafenib tosylate
BAY 43-9006 given orally at 400 mg BID in a 28 day cycle

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre - Calgary	Calgary	Alberta
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia
Canada	London Regional Cancer Program at London Health Sciences Centre	London	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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):746-5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate-specific antigen response and/or progression		2 years
Secondary	Objective response and/or progression		2 years
Secondary	Tolerability and toxicity		2 years
Secondary	Time to treatment failure and overall patient survival		2 years