- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94115
- UCSF Comprehensive Cancer Center
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Florida
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Tampa, Florida, États-Unis, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Masquage: Aucun (étiquette ouverte)
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDR0000269675
- VION-CLI-024
- MCC-13110
- MCC-IRB-100798
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