Status:
COMPLETED
Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Bristol-Myers Squibb
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 Phas...
Eligibility Criteria
Inclusion
- 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 http://www.mskcc.org/mskcc/html/10088.cfm may be used to access a prostate normogram calculator.)
- The following lab values must be obtained within 4 weeks prior to therapy:
- ANC ≥1500/mm³,
- Hemoglobin ≥ 10 g/dl
- Platelet count ≥ 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 ≥ 18 years of age.
- An estimated life expectancy of at least 6 months.
- ECOG performance status ≤ 2.
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00176605
Start Date
May 1 2005
End Date
October 1 2008
Last Update
May 20 2014
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Central Jersey Oncology Center
East Brunswick, New Jersey, United States, 08816
2
Robert Wood Johnson University Hospital/CINJ at Hamilton
Hamilton, New Jersey, United States, 08690
3
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
4
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901