NCT00176605

Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Etoposide	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.
DRUG	Cyclophosphamide	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

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2005-09-15
• Last updated: 2014-05-20
• Results posted: 2014-05-20

Locations

7 sites across 1 country: United States