Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer
- Registration Number
- NCT00005028
- Lead Sponsor
- University of Maryland, Baltimore
- Brief Summary
Phase II trial to study the effectiveness of combining paclitaxel and bryostatin 1 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
- Detailed Description
OBJECTIVES:
I. Determine the onset, duration, and degree of response in patients with hormone-refractory, metastatic adenocarcinoma of the prostate treated with paclitaxel and bryostatin 1.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I paclitaxel 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. Arm I bryostatin 1 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.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Wellspan Health - York Cancer Center
🇺🇸York, Pennsylvania, United States
Greater Baltimore Medical Center and Cancer Center
🇺🇸Baltimore, Maryland, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States