- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Vienna, Австрия, A-1100
- Kaiser Franz Josef Hospital
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Aalst, Бельгия, B-9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Brussels, Бельгия, 1200
- Cliniques Universitaires Saint-Luc
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Brussels, Бельгия, 1000
- Institut Jules Bordet
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Ghent, Бельгия, B-9000
- Universitair Ziekenhuis Gent
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Leuven, Бельгия, B-3000
- U.Z. Gasthuisberg
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Copenhagen, Дания, 2100
- Rigshospitalet - Copenhagen University Hospital
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Zerifin, Израиль, 70300
- Assaf Harofeh Medical Center
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Barcelona, Испания, 08035
- Hospital General Universitari Vall d'Hebron
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Rome, Италия, 00152
- Ospedale S. Camillo-Forlanini
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Amsterdam, Нидерланды, 1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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Warsaw, Польша, 02-781
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
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Lisboa, Португалия, 2700
- Hospital Desterro
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England
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London, England, Соединенное Королевство, EC1A 7BE
- Saint Bartholomew's Hospital
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Scotland
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Glasgow, Scotland, Соединенное Королевство, G11 6NT
- Western Infirmary
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Grenoble, Франция, 38043
- CHU de Grenoble - Hopital de la Tronche
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
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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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Вторичные показатели результатов
Мера результата |
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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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Соавторы и исследователи
Следователи
- Учебный стул: Cora N. Sternberg, MD, FACP, Azienda Ospedaliera S. Camillo-Forlanini
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Новообразования
- Урогенитальные новообразования
- Новообразования по локализации
- Генитальные новообразования, мужчины
- Заболевания предстательной железы
- Новообразования предстательной железы
- Молекулярные механизмы фармакологического действия
- Противоопухолевые агенты
- Модуляторы тубулина
- Антимитотические агенты
- Модуляторы митоза
- Доцетаксел
- Облимерсен
Другие идентификационные номера исследования
- EORTC-30021
- AVENTIS-AVE3139E/2501
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .