Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate
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|ClinicalTrials.gov Identifier: NCT00085228|
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : September 24, 2012
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: oblimersen sodium Drug: docetaxel||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|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|
|Actual Primary Completion Date :||January 2006|
- Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses
- Severe toxic events as measured by CTCAE v3.0 every course until progression or after 12 courses
- 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
- 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
- Objective response as measured by RECIST every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
- Overall survival as measured by Logrank every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085228
|Kaiser Franz Josef Hospital|
|Vienna, Austria, A-1100|
|Onze Lieve Vrouw Ziekenhuis Aalst|
|Aalst, Belgium, B-9300|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Universitair Ziekenhuis Gent|
|Ghent, Belgium, B-9000|
|Leuven, Belgium, B-3000|
|Rigshospitalet - Copenhagen University Hospital|
|Copenhagen, Denmark, 2100|
|CHU de Grenoble - Hopital de la Tronche|
|Grenoble, France, 38043|
|Assaf Harofeh Medical Center|
|Zerifin, Israel, 70300|
|Ospedale S. Camillo-Forlanini|
|Rome, Italy, 00152|
|Academisch Medisch Centrum at University of Amsterdam|
|Amsterdam, Netherlands, 1105 AZ|
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology|
|Warsaw, Poland, 02-781|
|Lisboa, Portugal, 2700|
|Hospital General Universitari Vall d'Hebron|
|Barcelona, Spain, 08035|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Cora N. Sternberg, MD, FACP||Azienda Ospedaliera S. Camillo-Forlanini|