Prostate Cancer Clinical Trial
Official title:
A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients
who have stage IV prostate cancer that has not responded to hormone therapy.
OBJECTIVES:
- Determine the efficacy of arsenic trioxide in patients with metastatic stage IVA or IVB
hormone-refractory prostate cancer.
- Determine the toxicity of this drug in this patient population.
- Assess, in a preliminary manner, the effect of this drug on pain control in these
patients.
- Assess the potential value of serial quantitative prostate-specific antigen (PSA) and
prostate-specific membrane antigen (PSMA) mRNA determinations in RNA from peripheral
blood mononuclear cells as surrogate markers of disease response in patients treated
with this drug.
- Assess the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Assess the feasibility of using pretreatment bone marrow evaluation of PSA and PMSA mRNA
levels and pi class glutathione S-transferase expression (i.e., eliminate glutathione
levels) as potential correlates of disease response in patients treated with this drug.
OUTLINE: Patients receive arsenic trioxide IV over 2 hours on days 1-5 and 8-12 for one
course. Treatment continues as biweekly infusions for at least 14 additional weeks in the
absence of disease progression, unacceptable toxicity, or excessive increase in serum
prostate-specific antigen.
Pain is assessed at baseline and then before each biweekly treatment.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 12-24
months.
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