- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00054015
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
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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California
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San Francisco, California, Forenede Stater, 94115
- UCSF Comprehensive Cancer Center
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Florida
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Tampa, Florida, Forenede Stater, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000269675
- VION-CLI-024
- MCC-13110
- MCC-IRB-100798
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