A Phase II Study of Doxorubicin and Cyclophosphamide With Sequential Docetaxel in Patients With Hormone-Refractory Prostate Cancer
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.
Interventional
Primary Purpose: Treatment
Debra Litwak, PharmD
Study Chair
Amgen
United States: Federal Government
CDR0000067942
NCT00005960
October 1999
Name | Location |
---|---|
New York Medical College | Valhalla, New York 10595 |
Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
Arena Oncology Associates | Great Neck, New York 11021 |
N.W. Carolina Oncology & Hematology, P.A. | Hickory, North Carolina 28603 |
Geffen Cancer Center and Research Institute | Vero Beach, Florida 32960-6541 |
Associates of Hematology/Oncology | Upland, Pennsylvania 19013 |