A Phase 2 interventional study of oblimersen sodium and docetaxel in Prostate Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 16 sites in 11 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-24.
Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 2, Interventional, and Treatment
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 116 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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European Organisation for Research and Treatment of Cancer - EORTC