Skip to content

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00054015
Enrollment
Unknown
Registered
2003-02-06
Start date
2002-12-31
Completion date
2008-01-31
Last updated
2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer, stage IV prostate cancer

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.

Detailed description

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.

Interventions

DRUGtriapine

Sponsors

Vion Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026