Combination Chemotherapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
- Conditions
- PainProstate Cancer
- Registration Number
- NCT00005960
- Lead Sponsor
- Amgen
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have prostate cancer that has not responded to hormone therapy.
- Detailed Description
OBJECTIVES: I. Determine the PSA response, duration of PSA response, disease free survival, median survival, and overall survival in patients with chemotherapy naive hormone refractory adenocarcinoma of the prostate treated with doxorubicin and cyclophosphamide with sequential docetaxel. II. Assess for any improvement in pain over time in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive doxorubicin IV over 3-5 minutes and cyclophosphamide IV on days 1, 22, 43, and 64, and docetaxel IV over 1 hour on days 85, 106, and 127 in the absence of disease progression or unacceptable toxicity. Patients receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after completion of chemotherapy infusions and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to starting subsequent chemotherapy infusions. Pain and analgesic use are assessed before study, every 3 weeks during study, after completion of study, and then at 3 months after completion of study. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter until death.
PROJECTED ACCRUAL: Approximately 42-105 patients will be accrued for this study over 18 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
New York Medical College
🇺🇸Valhalla, New York, United States
Arena Oncology Associates
🇺🇸Great Neck, New York, United States
Associates of Hematology/Oncology
🇺🇸Upland, Pennsylvania, United States
N.W. Carolina Oncology & Hematology, P.A.
🇺🇸Hickory, North Carolina, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸Los Angeles, California, United States
Geffen Cancer Center and Research Institute
🇺🇸Vero Beach, Florida, United States