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3-AP in Treating Patients With Advanced Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054015
First received: February 5, 2003
Last updated: November 5, 2013
Last verified: April 2004

February 5, 2003
November 5, 2013
December 2002
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Complete list of historical versions of study NCT00054015 on ClinicalTrials.gov Archive Site
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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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: triapine
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*   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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January 2008
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DISEASE CHARACTERISTICS:

  • 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 )

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • 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)

Hepatic

  • 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

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

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

Pulmonary

  • No dyspnea at rest

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 2 weeks since prior biologic therapy

Chemotherapy

  • 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

Radiotherapy

  • 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

Surgery

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

Other

  • No other concurrent investigational agents
  • No other concurrent anticancer treatment
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054015
CDR0000269675, VION-CLI-024, MCC-13110, MCC-IRB-100798
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Vion Pharmaceuticals
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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