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

NCT00218205 | Unknown Phase 2

• 1 other identifier: K-EPIRU-0030-280-US
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Epirubicin; Estramustine Phosphate; Celecoxib; Hormone Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• Evaluate the toxicity of the combination of epirubicin with estramustine phosphate and celecoxib in patients with stage D3 prostate cancer.

• Determine the effects of this regimen on quality of life.

• Determine the survival of the patients treated with the proposed regimen.

Interventions

Epirubicin DRUG

Estramustine Phosphate DRUG

Celecoxib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Department of Veterans Affairs, New Jersey: lead
• Pfizer: collaborator

Study Sites (1)

Department of Veterans Affairs NJ Health Care System

East Orange, New Jersey, 07018, United States

RECRUITING

Related 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 © Proc Am Soc Clin Oncol, Vol 24 #4754, 2005.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Epirubicin; Estramustine; Celecoxib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Basil Kasimis, MD

  Department of Veterans Affairs NJ Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basil Kasimis, MD

CONTACT

973-676-1000; basil.kasimis@med.va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2002
• Study Completion: June 1, 2006
• Last Updated: September 22, 2005

Record last verified: 2005-09

Locations

US (1)