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A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Patients With Advanced Prostate Cancer


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

Thank you

Trial Information

A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Patients With Advanced Prostate Cancer


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mario Sznol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vion Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000269675

NCT ID:

NCT00054015

Start Date:

December 2002

Completion Date:

Related Keywords:

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

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
UCSF Comprehensive Cancer CenterSan Francisco, California  94115