- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00060437
Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer
A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer
RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have prostate cancer that no longer responds to androgen ablation therapy.
Descripción general del estudio
Descripción detallada
OBJECTIVES:
- Determine the 4-month progression-free survival rate, as measured by prostate-specific antigen and clinical criteria, in patients with metastatic androgen-independent prostate cancer treated with perifosine.
- Determine the side-effect profile of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
OUTLINE:
- Course 1: Patients receive oral perifosine twice on day 1 and once daily on days 2-21.
- All subsequent courses: Patients receive oral perifosine once daily on days 1-21.
In all courses, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within approximately 1.5 years.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:
- Metastatic
- Androgen-independent
- Progressive disease while continuing to receive hormonal ablation (e.g., luteinizing hormone-releasing hormone [LHRH] agonist)
Progression documented by at least 1 of the following parameters:
- Two consecutively rising prostate-specific antigen levels, at least 1 week apart, with at least 1 measurement that is 50% above the nadir reached after the last treatment regimen (as long as the last measurement is at least 5 ng/mL)
- At least 1 new metastatic lesion on technetium Tc 99m bone scintigraphy
Progression of soft-tissue metastases as measured by appropriate modalities (i.e., imaging or palpation) and demonstrated by at least 1 of the following:
- Development of new area of malignant disease (measurable or nonmeasurable)
- At least a 20% increase in the sum of the longest diameters (LD) of target lesions from the smallest sum of LD recorded since the treatment started or the appearance of 1 or more new lesions
- Patients who have not undergone surgical castration must have a testosterone level less than 50 ng/mL and continue on their LHRH agonist during study treatment
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
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
Hepatic
- Bilirubin less than 1.0 mg/dL or upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No myocardial infarction within the past 6 months
- No unstable or newly diagnosed angina pectoris
- No New York Heart Association class II-IV congestive heart failure
Ophthalmic
- No pre-existing retinal disease
- No pathologic baseline electrooculogram
Other
- Fertile patients must use effective barrier contraception
- Able to ingest oral medication
- No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine (e.g., miltefosine or edelfosine)
- No ongoing or active infection
- No other concurrent uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- No other active malignancies within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 1 prior chemotherapy regimen
- More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin)
Endocrine therapy
- See Disease Characteristics
- More than 4 weeks since prior flutamide
- More than 6 weeks since prior bicalutamide or nilutamide
Radiotherapy
- At least 6 weeks since prior bone-seeking radioisotopes
- Recovered from prior radiotherapy
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- Recovered from any acute toxicity related to prior therapy
- More than 3 months since prior UCN-01
- More than 3 months since prior suramin
- No concurrent commercial or other investigational agents or therapies intended to treat the malignancy
- No concurrent combination antiretroviral therapy for HIV-positive patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Edwin M. Posadas, MD, National Cancer Institute (NCI)
Publicaciones y enlaces útiles
Publicaciones Generales
- Posadas EM, Gulley J, Arlen PM, Trout A, Parnes HL, Wright J, Lee MJ, Chung EJ, Trepel JB, Sparreboom A, Chen C, Jones E, Steinberg SM, Daniels A, Figg WD, Dahut WL. A phase II study of perifosine in androgen independent prostate cancer. Cancer Biol Ther. 2005 Oct;4(10):1133-7. doi: 10.4161/cbt.4.10.2064. Epub 2005 Oct 1.
- Posadas EM, Trout A, Senderowicz AM, et al.: A phase II trial of oral perifosine in patients with metastatic androgen-independent prostate cancer (AIPC). [Abstract] SUO/NCI Urologic Oncology Meeting, December 5-6, 2003, Bethesda, MD. A-54, 38, 2003.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000301951
- NCI-03-C-0157
- NCI-5970
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cancer de prostata
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
-
Rabin Medical CenterReclutamiento