A Phase 2 interventional study of docetaxel and doxorubicin hydrochloride in Prostate Cancer, sponsored by Wake Forest University Health Sciences. Completed. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-01-19.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel, doxorubicin, and prednisone together works in treating patients with advanced prostate cancer that has not responded to hormone therapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, doxorubicin hydrochloride IV over 15 minutes on days 1 and 8, and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, after completion of 3 courses, and at disease progression.
After completing study treatment, patients are followed every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 47 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate with any of the following:
PATIENT CHARACTERISTICS:
No previous history of or concurrent malignancy, except for any of the following:
PRIOR CONCURRENT THERAPY:
No study locations are listed for this record.
The record gives a start of Aug 2004 and a primary completion of Oct 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Docetaxel · Doxorubicin · Prednisone
Wake Forest University Health Sciences →