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A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.

Inclusion Criteria

Inclusion Criteria

- 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
ablation therapy.

- 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 may be used to access a prostate
normogram calculator.)

- 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
normal range.

- 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.

Exclusion Criteria

- 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
ablation therapy.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the PSA response from cyclical oral Etoposide and Cyclophosphamide administration for patients with stage D0 prostate cancer.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Mark Stein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

October 2008

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms



Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Overlook Hospital Summit, New Jersey  07902-0220
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
Robert Wood Johnson University Hospital/CINJ at Hamilton Hamilton, New Jersey  08690
UMDNJ/Robert Wood Johnson Medical School Newark, New Jersey  07103