A Study of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00218205
• Other study ID #: K-EPIRU-0030-280-US
• Status: Recruiting
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: September 20, 2005
• Start date: July 2002
• Est. completion date: June 2006

Study information

• Verified date: September 2005
• Source: Department of Veterans Affairs, New Jersey
• Contact: Basil Kasimis, MD
• Phone: 973-676-1000
• Email: basil.kasimis[@]med.va.gov
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to find out the effect of epirubicin with estramustine phosphate and celecoxib on PSA and objective response in patients with hormone resistant prostate cancer as well as evaluating the toxicity, quality of life of this combination. Celecoxib is an FDA approved drug to treat arthritis. Epirubicin, alone or with estramustine phosphate has been used in the treatment of hormone resistant prostate cancer. These drugs have demonstrated evidences of tumor blood vessel suppression and combination of these three drugs could possibly arrest further tumor growth or even make the tumor decrease in size.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 treatment.

• 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:

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Epirubicin

• Estramustine Phosphate

• Celecoxib

Locations

Country	Name	City	State
United States	Department of Veterans Affairs NJ Health Care System	East Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Department of Veterans Affairs, New Jersey	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zhong F, Kasimis B, Hwang S, Cogswell J, Chang V, Morales E, Gonzalez M, Boholli I, Ohanian M, Blumenfrucht M: Second Line Treatment of Hormone Resistant Prostate Cancer (HRPC). A Phase II Trial of Epirubicin (E), Estramustine Phosphate (EP) and Celecoxib

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the effect of epirubicin with estramustine phosphate and celecoxib on PSA and objective response in patients with HRPC
Secondary	Evaluate the toxicity of the combination of epirubicin with estramustine phosphate and celecoxib in patients with stage D3 prostate cancer.
Secondary	Determine the effects of this regimen on quality of life.
Secondary	Determine the survival of the patients treated with the proposed regimen.