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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Department of Veterans Affairs, New Jersey.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Department of Veterans Affairs, New Jersey
ClinicalTrials.gov Identifier:
NCT00218205
First received: September 20, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Epirubicin
Drug: Estramustine Phosphate
Drug: Celecoxib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Hormone Resistant Prostate Cancer (HRPC)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs, New Jersey:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 28
Study Start Date: July 2002
Estimated Study Completion Date: June 2006
  Eligibility

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

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218205

Contacts
Contact: Basil Kasimis, MD 973-676-1000 ext 1544 basil.kasimis@med.va.gov

Locations
United States, New Jersey
Department of Veterans Affairs NJ Health Care System Recruiting
East Orange, New Jersey, United States, 07018
Contact: Basil Kasimis, MD    973-676-1000 ext 1544    basil.kasimis@med.va.gov   
Sub-Investigator: Victor Chang, MD         
Sub-Investigator: Shanthi Srinivas, MD         
Sub-Investigator: Fengming Zhong, MD         
Sponsors and Collaborators
Department of Veterans Affairs, New Jersey
Pfizer
Investigators
Principal Investigator: Basil Kasimis, MD Department of Veterans Affairs NJ Health Care System
  More Information

Publications:
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.

ClinicalTrials.gov Identifier: NCT00218205     History of Changes
Other Study ID Numbers: K-EPIRU-0030-280-US
Study First Received: September 20, 2005
Last Updated: September 20, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs, New Jersey:
Epirubicin
Estramustine Phosphate
Celecoxib
Hormone Refractory Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Celecoxib
Epirubicin
Estramustine
Alkylating Agents
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014