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

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176605
First received: September 13, 2005
Last updated: April 18, 2014
Last verified: April 2014

September 13, 2005
April 18, 2014
May 2005
October 2008   (final data collection date for primary outcome measure)
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.
To evaluate the PSA response from cyclical oral Etoposide and Cyclophosphamide administration for patients with stage D0 prostate cancer.
Complete list of historical versions of study NCT00176605 on ClinicalTrials.gov Archive Site
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.
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.
Not Provided
Not Provided
 
Phase II Metronomic Dosing, Etoposide, Cyclophosphamide, D0 Prostate Cancer
A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage 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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Etoposide
    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
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.
Interventions:
  • Drug: Etoposide
  • Drug: Cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00176605
080408, P30CA072720, 0220044931, CDR0000443482
No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
  • National Cancer Institute (NCI)
  • Bristol-Myers Squibb
Principal Investigator: Mark Stein, MD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP