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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Aalst, België, B-9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Brussels, België, 1200
- Cliniques Universitaires Saint-Luc
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Brussels, België, 1000
- Institut Jules Bordet
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Ghent, België, B-9000
- Universitair Ziekenhuis Gent
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Leuven, België, B-3000
- U.Z. Gasthuisberg
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Copenhagen, Denemarken, 2100
- Rigshospitalet - Copenhagen University Hospital
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Grenoble, Frankrijk, 38043
- CHU de Grenoble - Hopital de la Tronche
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Zerifin, Israël, 70300
- Assaf Harofeh Medical Center
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Rome, Italië, 00152
- Ospedale S. Camillo-Forlanini
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Amsterdam, Nederland, 1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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Vienna, Oostenrijk, A-1100
- Kaiser Franz Josef Hospital
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Warsaw, Polen, 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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Barcelona, Spanje, 08035
- Hospital General Universitari Vall d'Hebron
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England
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London, England, Verenigd Koninkrijk, EC1A 7BE
- Saint Bartholomew's Hospital
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Scotland
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Glasgow, Scotland, Verenigd Koninkrijk, G11 6NT
- Western Infirmary
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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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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Secundaire uitkomstmaten
Uitkomstmaat |
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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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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Cora N. Sternberg, MD, FACP, Azienda Ospedaliera S. Camillo-Forlanini
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EORTC-30021
- AVENTIS-AVE3139E/2501
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
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University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
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BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
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Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
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Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Nog niet aan het wervenAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
Klinische onderzoeken op docetaxel
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Nereus Pharmaceuticals, Inc.VoltooidKankerVerenigde Staten, Australië, Indië, Chili, Brazilië, Argentinië
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Tianjin Medical University Cancer Institute and...Werving
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Optimal Health ResearchVoltooidBorstkanker | Longkanker | ProstaatkankerVerenigde Staten
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National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center en andere medewerkersOnbekend
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Zhuhai Beihai Biotech Co., LtdVoltooidVaste tumoren | Bio-equivalentie | DocetaxelIndië
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Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaVoltooidNiet-kleincellige longkanker (NSCLC)China
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Arog Pharmaceuticals, Inc.IngetrokkenCarcinoom, niet-kleincellige long
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Australian and New Zealand Urogenital and Prostate...Peter MacCallum Cancer Centre, AustraliaWervingCastratieresistente prostaatkankerAustralië
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SanofiVoltooid
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SanofiVoltooidLongneoplasmataFrankrijk, Nederland, Spanje, Kalkoen, België, Finland, Italië, Verenigd Koninkrijk