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A Phase II Trial of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Hormone Resistant Prostate Cancer (HRPC)

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase II Trial of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Hormone Resistant Prostate Cancer (HRPC)

Inclusion Criteria:

- Patient must have histologically proven adenocarcinoma of the prostate gland.

- Patient must have evidence of progressive metastatic disease (e.g., bone, pelvic
mass, lymph node, liver or lung metastases) within 6 weeks prior to participation in
the study.

- Patients must not have an elevated PSA level as the only evidence of disease. While
castrated, the patients should have rising PSA on two consecutive measurements at
least 1 week apart. The confirmatory PSA must be obtained within 1 week prior to
study registration and should be >10ng/ml.

- Patients with bone metastases only (i.e., lacking soft-tissue disease) must have a
PSA level of > 10 ng/ml. Patients with soft tissue metastases and /or visceral
disease must have either measurable disease or a PSA level of > 10 ng/ml.

- Radiological evidence of hydronephrosis will not by itself constitute evidence of
metastatic disease.

- Patients must have had prior treatment with bilateral orchiectomy or other primary
hormonal therapy (e.g., estrogen therapy, LHRH analog + flutamide, etc.) with
evidence of treatment failure.

NOTE: Patients who have not undergone bilateral orchiectomy must continue LHRH agonist
therapy (e.g., depot leuprolide or goserelin) while receiving this protocol therapy.

- For patients previously treated with flutamide (Eulexin), nilutamide (Nilandron), or
bicalutamide (Casodex): Patients must have discontinued flutamide or nilutamide < 4
weeks and for bicalutamide 6 weeks prior to registration.

- Patients should not have prior exposure to anthracyclines or estramustine phosphate.

- Patients must not have had prior radiotherapy < 4 weeks prior to this protocol

- Patients must not have previously received Strontium 89, Samarium 153, or other
radioisotope therapies.

- Patients must have recovered from all toxicities due to prior treatment for prostate
cancer prior to receiving this protocol treatment.

- Patients must have adequate bone marrow function: (WBC > 4000/ mm3, granulocytes >
2000/ mm3, platelet count > 100,000/mm3, and Hemoglobin > 8.0 g/dl < 4 weeks prior to
participate in this study.

- Patients must have the following chemistry values < 4 weeks prior to participate in
this study:

- Bilirubin < 1.5 mg/dl

- Transaminases (SGOT and/or SGPT) < 5 x institutional upper limit of normal (ULN)

- Creatinine < 2.0 mg/d. or creatinine clearance > 50 ml/min

- Alkaline phosphatase £ 5 x ULN

- Patients must have no active angina pectoris, or known heart disease of New York
Heart Association Class III-IV. Patients must not have a history of myocardial
infarction < 6 months prior to the study participation.

- Patients with a history of prior malignancy are eligible provided they were treated
with curative intent and have been free of disease for the time period considered
appropriate for the specific cancer.

- No serious concurrent medical illness or active infection should be present which
would jeopardize the ability of the patient to receive the chemotherapy outlined in
this protocol with reasonable safety.

- Sexually active patients must use an accepted and effective method of contraception
while receiving protocol treatment.

- Patients must have a Karnofsky Performance Scale (KPS) score over 50. (Equaling ECOG
Performance Scale of 0, 1, or 2).

- Age > 18 years.

- Patient must have failed the Taxotere treatment.

Exclusion Criteria:

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the effect of epirubicin with estramustine phosphate and celecoxib on PSA and objective response in patients with HRPC

Principal Investigator

Basil Kasimis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Veterans Affairs NJ Health Care System


United States: Food and Drug Administration

Study ID:




Start Date:

July 2002

Completion Date:

June 2006

Related Keywords:

  • Prostate Cancer
  • Epirubicin
  • Estramustine Phosphate
  • Celecoxib
  • Hormone Refractory Prostate Cancer
  • Prostatic Neoplasms



Department Of Veterans Affairs NJ Health Care System East Orange, New Jersey  07018