A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer
OBJECTIVES:
Primary
- Determine the prostate-specific antigen response in patients with stage D0 prostate
cancer treated with low-dose etoposide and cyclophosphamide.
Secondary
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive low-dose oral etoposide once daily on days 1-21 and low-dose oral
cyclophosphamide once daily on days 22-42. Treatment repeats every 42 days for up to 4
courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 8-12 weeks until disease
progression.
PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Prostate-specific antigen response
No
Mark Stein, MD
Study Chair
Cancer Institute of New Jersey
United States: Federal Government
CDR0000443482
NCT00227643
May 2005
October 2008
Name | Location |
---|---|
Overlook Hospital | Summit, New Jersey 07902-0220 |
Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown, New Jersey 07962 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
Saint Peter's University Hospital | New Brunswick, New Jersey 08901-1780 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Mountainside Hospital Cancer Center | Montclair, New Jersey 07042 |
Central Jersey Oncology Center, PA - East Brunswick | East Brunswick, New Jersey 08816 |