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Etoposide and Cyclophosphamide in Treating Patients With Stage D0 Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00227643
  Purpose

RATIONALE: Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Etoposide and cyclophosphamide may also stop the growth of prostate cancer by blocking blood flow to the tumor. Giving etoposide together with cyclophosphamide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving etoposide together with cyclophosphamide works in treating patients with stage D0 prostate cancer (stage IV prostate cancer that is seen only in the prostate after treatment) .


Condition Intervention Phase
Prostate Cancer
Drug: cyclophosphamide
Drug: etoposide
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Cyclophosphamide Etoposide Etoposide phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prostate-specific antigen response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: May 2005
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the prostate-specific antigen response in patients with stage D0 prostate cancer treated with low-dose etoposide and cyclophosphamide.

Secondary

  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive low-dose oral etoposide once daily on days 1-21 and low-dose oral cyclophosphamide once daily on days 22-42. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 8-12 weeks until disease progression.

PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer

    • Stage D0 disease

      • Disease limited to the prostate

        • Seminal vesicle involvement allowed provided all visible disease was removed by surgery
  • Rising prostate-specific antigen (PSA) after completing primary local therapy (surgery and/or radiotherapy) for prostate cancer ≥ 3 months ago

    • PSA ≥ 2 ng/mL documented by 2 measurements taken ≥ 4 weeks apart with a doubling time of ≤ 8 months

      • Final PSA measurement must be obtained within 1 week prior to study entry
  • Negative CT scan of the chest, abdomen, and pelvis and bone scan

    • Scans must be completed within 4 weeks prior to study entry

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • SGOT and SGPT ≤ 1.5 times upper limit of normal
  • Bilirubin ≤ 1.5 mg/dL
  • No uncontrolled hepatic disease

Renal

  • Creatinine ≤ 1.5 mg/dL
  • No uncontrolled renal disease

Cardiovascular

  • No uncontrolled cardiac disease

Other

  • Fertile patients must use effective barrier contraception during and for 4 weeks after completion of study treatment
  • No active infection
  • No known HIV positivity
  • No other uncontrolled medical condition, defined as ≥ grade 3
  • No uncontrolled psychiatric disease
  • No diagnosis of major depression or suicidal ideation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 5 years since prior chemotherapy
  • No prior treatment with cyclophosphamide or etoposide that lasted for > 2 months

Endocrine therapy

  • At least 1 year since prior androgen-ablation therapy and recovered

    • No disease progression during therapy

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • No other concurrent investigational agents
  • No concurrent cyclosporine, succinylcholine chloride, or phenobarbital
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227643

Locations
United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903
Overlook Hospital
Summit, New Jersey, United States, 07901
Mountainside Hospital Cancer Center
Montclair, New Jersey, United States, 07042
Sponsors and Collaborators
Cancer Institute of New Jersey
Investigators
Study Chair: Mark Stein, MD Cancer Institute of New Jersey
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Mark Stein )
Study ID Numbers: CDR0000443482, CINJ-080408-4931
Study First Received: September 26, 2005
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00227643  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Cyclophosphamide
Genital Diseases, Male
Etoposide phosphate
Etoposide
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009