Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate
- Conditions
- Prostate Cancer
- Registration Number
- NCT00085228
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 116
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (16)
Rigshospitalet - Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Institut Jules Bordet
🇧🇪Brussels, Belgium
CHU de Grenoble - Hopital de la Tronche
🇫🇷Grenoble, France
Hospital General Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Ospedale S. Camillo-Forlanini
🇮🇹Rome, Italy
Assaf Harofeh Medical Center
🇮🇱Zerifin, Israel
Hospital Desterro
🇵🇹Lisboa, Portugal
Onze Lieve Vrouw Ziekenhuis Aalst
🇧🇪Aalst, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Academisch Medisch Centrum at University of Amsterdam
🇳🇱Amsterdam, Netherlands
Western Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
🇵🇱Warsaw, Poland
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom