Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004149
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 8, 2011
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: arsenic trioxide Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer
Study Start Date : September 1999

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Diagnosis of stage IVA or IVB hormone-refractory prostate cancer

    • Evidence of metastatic disease by physical exam, bone scan, abdominal or pelvic CT scan, or chest X-ray
    • Must have failed at least 2 prior hormonal therapy regimens (e.g., luteinizing hormone-releasing hormone [LHRH] agonist plus antiandrogen and antiandrogen withdrawal)
    • Must have 2 successive increases in serum prostate-specific antigen (PSA) levels to at least 10 ng/mL measured at least 2 weeks apart
    • Must have castrate testosterone levels (no greater than 50 ng/dL) due to prior orchiectomy or continuing LHRH agonist therapy
  • Obstructive uropathy and/or hydronephrosis allowed if adequate renal function and urinary drainage



  • Any age

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • WBC at least 2,500/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL


  • Bilirubin less than 2 mg/dL
  • Transaminases less than 2.5 times upper limit of normal


  • See Disease Characteristics
  • Creatinine less than 2 mg/dL
  • Potassium between 4.0 and 5.5 mEq/L OR
  • Magnesium between 1.5 and 2.5 mEq/L


  • No second-degree heart block without permanent pacemaker
  • QT interval under 500 milliseconds


  • No significant active infectious disease
  • No grade 2 or greater peripheral neuropathy
  • No other debilitating acute or chronic co-morbid medical, neurological, or psychiatric condition that would preclude study compliance


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas and 8 weeks for suramin) and recovered

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior antiandrogen therapy (6 weeks for bicalutamide) (if PSA is increased from baseline)
  • At least 2 weeks since prior corticosteroid therapy and recovered


  • At least 2 weeks since prior radiotherapy (4 weeks for strontium chloride Sr 90) and recovered


  • See Disease Characteristics
  • Recovered from prior surgery


  • Recovered from acute toxicity of prior therapy
  • At least 3 weeks since prior bisphosphonates
  • No concurrent amphotericin B or other agent that prevents restoration of potassium or magnesium to normal levels and/or correction of QT interval to under 500 milliseconds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004149

United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10467
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
National Cancer Institute (NCI)
Study Chair: Robert E. Gallagher, MD Albert Einstein College of Medicine, Inc.

Publications of Results:
Gallagher RE, Ferrari A, Kaubisch A, et al.: Arsenic trioxide (ATO) in metastatic hormone-refractory prostate cancer (HRPC): results of phase II trial T99-0077. [Abstract] J Clin Oncol 22 (Suppl 14): A-4638, 2004. Identifier: NCT00004149     History of Changes
Other Study ID Numbers: CDR0000067382
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 8, 2011
Last Verified: July 2004

Keywords provided by National Cancer Institute (NCI):
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Arsenic trioxide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents