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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)

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 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy.

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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Patients With Advanced Prostate Cancer
Study Start Date : December 2002
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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

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): NCT00054015

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United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
Vion Pharmaceuticals
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Study Chair: Mario Sznol, MD Vion Pharmaceuticals

Layout table for additonal information Identifier: NCT00054015    
Other Study ID Numbers: CDR0000269675
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: April 2004
Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases