Know Cancer

or
forgot password

A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer


Phase 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert E. Gallagher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University

Authority:

United States: Federal Government

Study ID:

CDR0000067382

NCT ID:

NCT00004149

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Mount Sinai Medical Center, NYNew York, New York  10029
Albert Einstein Clinical Cancer CenterBronx, New York  10461
Jacobi Medical CenterBronx, New York  10461