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Sponsored by: |
European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085228 |
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.
Condition | Intervention | Phase |
Prostate Cancer |
Drug: docetaxel Drug: oblimersen |
Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Docetaxel Oblimersen sodium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | 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 |
Study Start Date: | April 2004 |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone-refractory disease
Prostate-specific antigen (PSA) progression documented by at least 2 increases in PSA values over previous PSA reference value
No evidence of painful and/or destructive bone metastases requiring concurrent radiotherapy, bisphosphonates, or bone-seeking radionuclides
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Austria | |||||
Kaiser Franz Josef Hospital | |||||
Vienna, Austria, A-1100 | |||||
Belgium | |||||
Cliniques Universitaires Saint-Luc | |||||
Brussels, Belgium, 1200 | |||||
Institut Jules Bordet | |||||
Brussels, Belgium, 1000 | |||||
Onze Lieve Vrouw Ziekenhuis Aalst | |||||
Aalst, Belgium, B-9300 | |||||
U.Z. Gasthuisberg | |||||
Leuven, Belgium, B-3000 | |||||
Universitair Ziekenhuis Gent | |||||
Ghent, Belgium, B-9000 | |||||
Denmark | |||||
Rigshospitalet - Copenhagen University Hospital | |||||
Copenhagen, Denmark, 2100 | |||||
France | |||||
CHU de Grenoble - Hopital de la Tronche | |||||
Grenoble, France, 38043 | |||||
Israel | |||||
Assaf Harofeh Medical Center | |||||
Zerifin, Israel, 70300 | |||||
Italy | |||||
Ospedale S. Camillo-Forlanini | |||||
Rome, Italy, 00152 | |||||
Netherlands | |||||
Academisch Medisch Centrum at University of Amsterdam | |||||
Amsterdam, Netherlands, 1105 AZ | |||||
Poland | |||||
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |||||
Warsaw, Poland, 02-781 | |||||
Portugal | |||||
Hospital Desterro | |||||
Lisboa, Portugal, 2700 | |||||
Spain | |||||
Hospital General Universitari Vall d'Hebron | |||||
Barcelona, Spain, 08035 | |||||
United Kingdom, England | |||||
Saint Bartholomew's Hospital | |||||
London, England, United Kingdom, EC1A 7BE | |||||
United Kingdom, Scotland | |||||
Western Infirmary | |||||
Glasgow, Scotland, United Kingdom, G11 6NT |
European Organization for Research and Treatment of Cancer |
Investigator: | Cora N. Sternberg, MD, FACP | Azienda Ospedaliera S. Camillo-Forlanini |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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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.
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Study ID Numbers: | CDR0000367489, EORTC-30021, AVENTIS-AVE3139E/2501 |
First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00085228 |
Health Authority: | United States: Federal Government |
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