At a glance
ClinicalIndex Comparison Record- ✓Histologically proven prostate cancer limited to the prostate (including seminal vesicle involvement if surgically removed) with rising PSA after completed local therapy
- ✓PSA >2 ng/ml with doubling time ≤12 months, documented by two measurements ≥4 weeks apart
- ✓Primary treatment (surgery and/or radiation) completed ≥3 months prior to entry
- ✓Negative CT chest/abdomen/pelvis and bone scan within 4 weeks prior to therapy start
- ✕Prior chemotherapy within the past 5 years
- ✕More than 2 months of prior therapy with etoposide or cyclophosphamide
- ✕Active infections or known HIV infection
- ✕Use of androgen ablation therapy within 1 year or history of progression on androgen ablation therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.
In Brief
A Phase 2 clinical trial evaluating Etoposide and Cyclophosphamide for Prostate Cancer. Completed, enrolled 15 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
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