Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostate-specific antigen response and/or progression

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Kim N. Chi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Canada: Health Canada

Study ID:

I167

NCT ID:

NCT00093457

Start Date:

July 2004

Completion Date:

January 2011

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage IV prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location