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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004149
First received: December 10, 1999
Last updated: July 7, 2011
Last verified: July 2004
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: arsenic trioxide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1999
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004149

Locations
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10467
Jacobi Medical Center
Bronx, New York, United States, 10461
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Study Chair: Robert E. Gallagher, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004149     History of Changes
Other Study ID Numbers: CDR0000067382, AECM-1199908270, NCI-T99-0077, AECM-CCRC-9929
Study First Received: December 10, 1999
Last Updated: July 7, 2011
Health Authority: United States: Federal Government

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014