A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.
- Patients with histologically proven prostate cancer and tumors limited to the
prostate (including seminal vesicle involvement, provided all visible disease was
surgically removed) that have completed local therapy and have an rising PSA value,
as defined in Section 5.1.5.
- Prior androgen ablation therapy is allowed as long as the patient completed therapy
at least 1 year prior to entry into this study. The patient must be fully recovered
from such therapy and must not have demonstrated progression while on androgen
- Primary treatment to the prostate (surgery and/or radiation) must have been completed
at least 3 months prior to entry into this study and the patient must be fully
recovered from such therapy.
- Patients must have a negative CT of the chest, abdomen and pelvis and bone scan. The
scans must be completed within 4 weeks prior to the date of starting therapy.
- PSA value for patients enrolled must be > 2 ng/ml with a doubling time of £ 12
months. PSA value > 2 ng/ml must be documented by two measurements at least four
weeks apart. The final PSA measurement before study entry must be obtained within
one week prior to therapy. This will be considered the baseline PSA. (Note: The
website http://www.mskcc.org/mskcc/html/10088.cfm may be used to access a prostate
- The following lab values must be obtained within 4 weeks prior to therapy:
- ANC ³1500/mm³,
- Hemoglobin > 10 g/dl
- Platelet count ³ 100,000/mm³
- Serum creatinine £ 1.5 mg/dL
- Total bilirubin £ 1.5 mg/dL
- Liver function tests (SGOT, SGPT) £ 1.5 times the upper limit of the institution's
- Men ³ 18 years of age.
- An estimated life expectancy of at least 6 months.
- ECOG performance status £ 2. (see Appendix B)
- Able to give informed, written consent.
- Men must consent to using effective contraception (barrier method- latex condom)
while on treatment and for 4 weeks after discontinuation of treatment.
- Patients with active infections or known infection with HIV (HIV testing will not be
performed as part of this study).
- Any coexisting medical condition including uncontrolled cardiac, hepatic, renal or
psychiatric disease defined as ³ Grade 3 (CTCAE Version 3).
- Concurrent use of other investigational agent.
- Patients that have previously received more than 2 months of therapy with any of the
agents used in this study.
- PSA value < 2 ng/ml.
- Prior chemotherapy in the past 5 years.
- Use of androgen ablation therapy within 1 year, or history of progression on androgen