3-AP in Treating Patients With Advanced Prostate Cancer
This study is no longer recruiting patients.
Sponsored by: |
Vion Pharmaceuticals |
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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.
Condition
|
Treatment or Intervention |
Phase |
recurrent prostate cancer stage IV prostate cancer
|
Drug: 3-AP Procedure: chemotherapy
|
Phase II
|
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of 3-AP in Patients With Advanced Prostate Cancer
Further Study Details:
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.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Performance status
Life expectancy
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
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
Location
Information
California UCSF Comprehensive Cancer Center, San Francisco,
California,
94115,
United States
Florida H. Lee Moffitt Cancer Center and Research Institute, Tampa,
Florida,
33612-9497,
United States
Study chairs or principal investigators
Mario Sznol, MD, Study Chair, Vion Pharmaceuticals
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000269675; VION-CLI-024; MCC-13110; MCC-IRB-100798
Record last reviewed:
June 2004
Record first received:
February 5, 2003
ClinicalTrials.gov Identifier:
NCT00054015Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22