Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer
I. Determine the onset, duration, and degree of response in patients with
hormone-refractory, metastatic adenocarcinoma of the prostate treated with paclitaxel and
II. Determine the toxicity of this regimen in these patients. III. Determine the overall
survival of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1
hour on days 2, 9, and 16. Treatment repeats every 4 weeks in the absence of disease
progression or unacceptable toxicity.
Patients are followed monthly for 6 months and then every 3 months thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Arif Hussain, MD
University of Maryland Greenebaum Cancer Center
United States: Food and Drug Administration
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Greater Baltimore Medical Center and Cancer Center||Baltimore, Maryland 21204|
|Wellspan Health - York Cancer Center||York, Pennsylvania 17403|