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

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ClinicalTrials.gov Identifier: NCT00004149
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 8, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

December 10, 1999
January 27, 2003
July 8, 2011
September 1999
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Complete list of historical versions of study NCT00004149 on ClinicalTrials.gov Archive Site
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Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
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.

Interventional
Phase 2
Primary Purpose: Treatment
Prostate Cancer
Drug: arsenic trioxide
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • 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

Hepatic:

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

Renal:

  • 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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery

Other:

  • 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
Sexes Eligible for Study: Male
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00004149
CDR0000067382
AECM-1199908270
NCI-T99-0077
AECM-CCRC-9929
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Albert Einstein College of Medicine, Inc.
National Cancer Institute (NCI)
Study Chair: Robert E. Gallagher, MD Albert Einstein College of Medicine, Inc.
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP