Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

• Status: Completed
• Trial end date: 2011-01-18
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sorafenib

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