- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00085228
Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate
Randomized Phase II Trial of Docetaxel (Taxotere) and Oblimersen (Antisense Oligonucleotide Directed to BCL-2) Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making tumor cells more sensitive to the drug.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with oblimersen works compared to docetaxel alone in treating patients with hormone-refractory adenocarcinoma (cancer) of the prostate.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
Primary
- Compare the activity of docetaxel with or without oblimersen, in terms of prostate-specific antigen response, in patients with hormone-refractory adenocarcinoma of the prostate.
- Compare the toxicity of these regimens in these patients.
Secondary
- Compare the time to progression in patients treated with these regimens.
- Compare survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, metastatic disease (M0 vs M1 with non-measurable lesions only vs M1 with measurable lesions), prior estramustine (yes vs no), and prior bisphosphonates (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 5 and oblimersen IV continuously on days 1-7.
- Arm II: Patients receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until progressive disease and then every 16 weeks thereafter.
PROJECTED ACCRUAL: A total of 102 patients (51 per treatment arm) will be accrued for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Vienna, Austria, A-1100
- Kaiser Franz Josef Hospital
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Aalst, Bélgica, B-9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Brussels, Bélgica, 1200
- Cliniques universitaires Saint-Luc
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Brussels, Bélgica, 1000
- Institut Jules Bordet
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Ghent, Bélgica, B-9000
- Universitair Ziekenhuis Gent
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Leuven, Bélgica, B-3000
- U.Z. Gasthuisberg
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Copenhagen, Dinamarca, 2100
- Rigshospitalet - Copenhagen University Hospital
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Barcelona, España, 08035
- Hospital General Universitari Vall d'Hebron
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Grenoble, Francia, 38043
- CHU de Grenoble - Hopital de la Tronche
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Zerifin, Israel, 70300
- Assaf Harofeh Medical Center
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Rome, Italia, 00152
- Ospedale S. Camillo-Forlanini
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Amsterdam, Países Bajos, 1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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Warsaw, Polonia, 02-781
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
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Lisboa, Portugal, 2700
- Hospital Desterro
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England
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London, England, Reino Unido, EC1A 7BE
- Saint Bartholomew's Hospital
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Scotland
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Glasgow, Scotland, Reino Unido, G11 6NT
- Western Infirmary
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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
Hormone-refractory disease
- Disease progression after prior hormonal therapy with luteinizing hormone-releasing hormone (LH-RH) analogues or orchiectomy and antiandrogens (given together or consecutively)
Prostate-specific antigen (PSA) progression documented by at least 2 increases in PSA values over previous PSA reference value
- Must demonstrate continued PSA elevation for at least 6 weeks after discontinuation of antiandrogen therapy
- PSA ≥ 5 ng/mL (Hybritech or equivalent) within the past week
- Testosterone ≤ 0.5 ng/mL* NOTE: *Patients with medical castration with LH-RH analogue must continue with LH-RH analogue throughout the study
No evidence of painful and/or destructive bone metastases requiring concurrent radiotherapy, bisphosphonates, or bone-seeking radionuclides
- Other bone metastases allowed
- No clinical evidence of brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- WBC ≥ 3,500/mm^3
- Hemoglobin ≥ 10 g/dL
Hepatic
- AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ ULN
- PTT and PT ≤ 1.5 times ULN OR
- INR ≤ 1.3
Renal
- Creatinine ≤ 1.5 times ULN OR
- Creatinine clearance ≥ 50 mL/min
Cardiovascular
- No unstable angina
- No uncontrolled hypertension
- No deep venous thrombosis within the past 6 months
- No cerebrovascular accident, transient ischemic attack, or myocardial infarction within the past 6 months
Pulmonary
- No pulmonary embolism
- No history of interstitial pneumonitis
- No history of pulmonary fibrosis
Other
- Adequate venous access
- HIV negative
- No active infection
- No pre-existing neuropathy
- No hypersensitivity to phosphorothioates
- No hypersensitivity to oligonucleotides or any other component of the oblimersen formulation or to drugs formulated with polysorbate
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
- No other malignancy within the past 5 years except adequately treated superficial urothelial or skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Prior estramustine allowed
- No other prior chemotherapy
- No concurrent estramustine
Endocrine therapy
- See Disease Characteristics
- At least 6 weeks since prior flutamide, bicalutamide, or nilutamide
- More than 6 weeks since prior hormonal manipulation with PC-SPES
- Concurrent LH-RH agonist allowed
- No concurrent antiandrogens
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy involving > 25% of marrow-producing area
- No prior bone-seeking radionuclides
- No concurrent radiotherapy (including palliative therapy for painful bone metastases)
- No concurrent bone-seeking radionuclides
Surgery
- See Disease Characteristics
Other
- Prior bisphosphonates allowed
- No concurrent anticoagulation except for low-dose warfarin (1 mg/day)
- No concurrent regular (daily) intake of opioid analgesics
- No other concurrent experimental drugs or anticancer drugs
- No concurrent bisphosphonates
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses
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Severe toxic events as measured by CTCAE v3.0 every course until progression or after 12 courses
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Medidas de resultado secundarias
Medida de resultado |
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Time to progression as measured by RECIST and Bubley criteria every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
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Toxicity as measured by CTCAE v3.0 every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
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Objective response as measured by RECIST every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
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Overall survival as measured by Logrank every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
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Colaboradores e Investigadores
Investigadores
- Silla de estudio: Cora N. Sternberg, MD, FACP, Azienda Ospedaliera S. Camillo-Forlanini
Publicaciones y enlaces útiles
Publicaciones Generales
- Sternberg CN, Dumez H, Van Poppel H, Skoneczna I, Sella A, Daugaard G, Gil T, Graham J, Carpentier P, Calabro F, Collette L, Lacombe D; EORTC Genitourinary Tract Cancer Group. Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer. Ann Oncol. 2009 Jul;20(7):1264-9. doi: 10.1093/annonc/mdn784. Epub 2009 Mar 17.
- Sternberg CN, Dumez H, Van Poppel H, et al.: Multicenter randomized EORTC trial 30021 of docetaxel + oblimersen and docetaxel in patients (pts) with hormone refractory prostate cancer (HRPC). [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-144, 2007.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (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
- EORTC-30021
- AVENTIS-AVE3139E/2501
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. .
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