Based on data supporting the use of cyclophosphamide and etoposide both as single agents in combination and a Phase I study showing acceptable toxicity with a chronic dosing regimen, we propose a Phase II clinical trial. This protocol establishes a model that will test the hypothesis that the use of etoposide and cyclophosphamide early in the course of prostate cancer progression, when fewer tumor cells are present, will have greater anti-tumor activity. We plan to treat patients with stage D0 prostate cancer to assess toxicity and anti-tumor activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
50 mg per day of Etoposide orally for 21 consecutive days. Etoposide will be alternated with oral cyclophosphamide. The drug is administered at night just prior to bed. Week 1 of each cycle will begin with etoposide.
50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration of cyclophosphamide at this dose has been well tolerated
Central Jersey Oncology Center
East Brunswick, New Jersey, United States
Robert Wood Johnson University Hospital/CINJ at Hamilton
Hamilton, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
PSA Response Rate
The PSA response rate is the percentage of patients who have a PSA response. A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Patients may not demonstrate clinical or radiographic evidence of disease progression during this period.
Time frame: 5 years
Toxicities Related to Chronic Administration of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.
All patients who receive one dose of protocol therapy will be evaluable for toxicity. A total of 15 patients received at least one dose of protocol therapy. Adverse events are described in Adverse Event section.
Time frame: 5 years
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Saint Peter's University Hospital
New Brunswick, New Jersey, United States
UMDNJ/Robert Wood Johnson Medical School
Newark, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States