3-AP in Treating Patients With Advanced Prostate Cancer

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: NCT00054015
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : November 6, 2013
Information provided by:
National Cancer Institute (NCI)

February 5, 2003
February 6, 2003
November 6, 2013
December 2002
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00054015 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
3-AP in Treating Patients With Advanced Prostate Cancer
A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Patients With Advanced 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 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy.


  • Determine the response rate in patients with advanced hormone-refractory prostate cancer treated with 3-AP.
  • Determine the toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 3-AP IV over 2 hours on days 1-4. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2-3 months for up to 1 year.

PROJECTED ACCRUAL: Approximately 13-27 patients will be accrued for this study.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: triapine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided
January 2008
Not Provided


  • Diagnosis of hormone-refractory metastatic prostate cancer by one of the following methods:

    • Measurable disease
    • PSA level of at least 5 ng/mL with a positive bone scan
  • Objective evidence of progressive metastatic disease in the past 3 months defined by any of the following:

    • An increase in PSA value of at least 25% (minimum absolute increase of 5 ng/mL) on at least 2 successive occasions, at least 2 weeks apart
    • A new symptomatic lesion on bone scan
    • A new metastases not in bone
    • Growth of existing non-bone measurable metastatic disease NOTE: An increase in pain or symptoms alone without other evidence of progression, or elevation of PSA or serum alkaline phosphatase alone without evidence of metastatic disease is not sufficient
  • Prior bilateral orchiectomy or other primary hormonal treatment with evidence of treatment failure

    • Patients with no prior bilateral orchiectomy must have a testosterone level less than 50 ng/mL and must continue leuteinizing hormone-releasing hormone therapy while on study
  • No known active CNS metastases (excluding prior CNS metastases with currently stable disease after treatment )



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL (transfusion allowed)


  • Bilirubin no greater than 2.0 mg/dL
  • ALT/AST no greater than 5 times upper limit of normal
  • Albumin greater than 2.5 g/dL
  • Chronic hepatitis allowed


  • Creatinine no greater than 2.0 mg/dL


  • No myocardial infarction within the past 3 months
  • No unstable angina
  • No uncontrolled arrhythmias
  • No uncontrolled congestive heart failure


  • No dyspnea at rest


  • Nutrition adequate (caloric intake considered adequate for maintenance of weight)
  • Fertile patients must use effective contraception
  • No prior or concurrent malignancies except for non-metastatic basal cell or squamous cell skin cancer or any stage I malignancy curatively resected more than 5 years ago
  • No active uncontrolled infectious process
  • No other life-threatening illness
  • No peripheral neuropathy greater than grade 2


Biologic therapy

  • At least 2 weeks since prior biologic therapy


  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since other prior hormonal therapy including any of the following:

    • Megestrol
    • Finasteride
    • Herbal products known to decrease PSA levels (e.g., saw palmetto and PC-SPES)
    • Systemic corticosteroids
  • At least 4 weeks since prior flutamide therapy (6 weeks for bicalutamide or nilutamide) with continued evidence of progressive disease documented by at least 1 PSA value after discontinuation


  • At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium)
  • At least 4 weeks since prior radiotherapy and recovered


  • See Disease Characteristics
  • At least 3 weeks since prior major surgery and recovered


  • No other concurrent investigational agents
  • No other concurrent anticancer treatment
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
Vion Pharmaceuticals
Not Provided
Study Chair: Mario Sznol, MD Vion Pharmaceuticals
National Cancer Institute (NCI)
April 2004

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