Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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|
- Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses [ Designated as safety issue: No ]
- Severe toxic events as measured by CTCAE v3.0 every course until progression or after 12 courses [ Designated as safety issue: Yes ]
- 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 [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: Yes ]
- Objective response as measured by RECIST every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death [ Designated as safety issue: No ]
- Overall survival as measured by Logrank every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
- 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.
|Kaiser Franz Josef Hospital|
|Vienna, Austria, A-1100|
|Onze Lieve Vrouw Ziekenhuis Aalst|
|Aalst, Belgium, B-9300|
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|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|