3-AP in Treating Patients With Advanced Prostate Cancer

NCT ID: NCT00054015

Last Updated: 2013-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2008-01-31

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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; stage IV prostate cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

triapine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Vion Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Mario Sznol, MD

Role: STUDY_CHAIR

Vion Pharmaceuticals

Locations

UCSF Comprehensive Cancer Center

San Francisco, California, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

VION-CLI-024

Identifier Type: -

Identifier Source: secondary_id

MCC-13110

Identifier Type: -

Identifier Source: secondary_id

MCC-IRB-100798

Identifier Type: -

Identifier Source: secondary_id

CDR0000269675

Identifier Type: -

Identifier Source: org_study_id