Prostate Cancer Clinical Trial

3-AP in Treating Patients With Advanced Prostate Cancer

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Study ID:

NCT00054015

Recruitment Status:

Completed

Sponsor:

Vion Pharmaceuticals

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There are 2 Locations for this study

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UCSF Comprehensive Cancer Center
San Francisco California, 94115, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Study ID:

NCT00054015

Recruitment Status:

Completed

Sponsor:


Vion Pharmaceuticals

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