Clinical trial NCT00176605: Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate Cancer
Official title: A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
recurrent prostate cancer
stage IV prostate cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Bristol-Myers Squibb
First posted: 2005-09-15
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: PSA Response Rate
timeFrame: 5 years
Secondary outcomes:
measure: Toxicities Related to Chronic Administration of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer.
timeFrame: 5 years
Other outcomes:
Locations:
city: East Brunswick
country: United States
facility: Central Jersey Oncology Center
state: New Jersey
city: Hamilton
country: United States
facility: Robert Wood Johnson University Hospital/CINJ at Hamilton
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Newark
country: United States
facility: UMDNJ/Robert Wood Johnson Medical School
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Mark Stein, MD
role: PRINCIPAL_INVESTIGATOR
References: