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

This study has been completed.
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176605
First received: September 13, 2005
Last updated: January 25, 2010
Last verified: January 2010
  Purpose

This study will evaluate a treatment, which is the combination of two (2) medications, which will taken by mouth: etoposide (also known as VePesid®) and cyclophosphamide (also known as Cytoxan®). This study will evaluate how the subject's PSA responds (if it increases, decreases or stays the same) after treatment with these medicines, and to see what side effects may happen. About 39 men are expected to take part in this study. The total duration of therapy is 24weeks.Treatment Plan:The treatment will be divided into four (4) cycles. Each cycle is equal to six (6) weeks. The total time of treatment is 24 weeks).Etoposide (VePesid®): will be taken by mouth every day for three (3) weeks, followed by three (3) weeks off. The dose is 50 mg. The medication will be taken at bedtime.Cyclophosphamide (Cytoxan®): will be taken by mouth every day for three (3) weeks, then the subject will take etoposide (VePesid®) for the next three (3) weeks. The dose is 50 mg. The subject will take this medication 2 hours after breakfast. The subject will be asked to increase their fluid intake by drinking at least 6, 8oz glasses of water or other non-caffeinated beverage throughout the day.


Condition Intervention Phase
Prostate Cancer
Drug: Etoposide
Drug: Cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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.

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • To evaluate the PSA response from cyclical oral Etoposide and Cyclophosphamide administration for patients with stage D0 prostate cancer. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate and document toxicities from chronic administration of these two drugs at the doses prescribed in this protocol in patients with stage D0 prostate cancer. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: May 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Etoposide
    take 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 ³1500/mm³,
  • Hemoglobin > 10 g/dl
  • Platelet count ³ 100,000/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 ³ 18 years of age.
  • An estimated life expectancy of at least 6 months.
  • ECOG performance status £ 2. (see Appendix B)
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176605

Locations
United States, New Jersey
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
Overlook Hospital
Summit, New Jersey, United States, 070901
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Mark Stein, MD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Mark Stein, M.D., The Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT00176605     History of Changes
Obsolete Identifiers: NCT00227643
Other Study ID Numbers: 4931, CINJ#080408
Study First Received: September 13, 2005
Last Updated: January 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cyclophosphamide
Etoposide phosphate
Etoposide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014