Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate Cancer
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.|
- PSA Response Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
- Toxicities Related to Chronic Administration of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||May 2005|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm 1 (Etoposide + Cyclophosphamide)
Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy. Total duration of therapy is 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Therapy will continue in this alternating manner for 24 weeks. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176605
|United States, New Jersey|
|Central Jersey Oncology Center|
|East Brunswick, New Jersey, United States, 08816|
|Robert Wood Johnson University Hospital/CINJ at Hamilton|
|Hamilton, New Jersey, United States, 08690|
|Morristown Memorial Hospital|
|Morristown, New Jersey, United States, 07962|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|Saint Peter's University Hospital|
|New Brunswick, New Jersey, United States, 08903|
|UMDNJ/Robert Wood Johnson Medical School|
|Newark, New Jersey, United States, 07103|
|Summit, New Jersey, United States, 070901|
|Principal Investigator:||Mark Stein, MD||Rutgers, The State University of New Jersey|