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A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Phase II Trial of Metronomic Dosing of Etoposide and Cyclophosphamide in Patients With Stage D0 Prostate Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostate-specific antigen response

Safety Issue:

No

Principal Investigator

Mark Stein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000443482

NCT ID:

NCT00227643

Start Date:

May 2005

Completion Date:

October 2008

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Overlook Hospital Summit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown, New Jersey  07962
Cancer Institute of New Jersey at Hamilton Hamilton, New Jersey  08690
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Mountainside Hospital Cancer Center Montclair, New Jersey  07042
Central Jersey Oncology Center, PA - East Brunswick East Brunswick, New Jersey  08816