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

NCT00218205

Last updated date
Study Location
Department of Veterans Affairs NJ Health Care System
East Orange, New Jersey, 07018, United States
Contact
973-676-1000

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Prostate Cancer
Official Title  ICMJE A Phase II Trial of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Hormone Resistant Prostate Cancer (HRPC)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Epirubicin
  • Drug: Estramustine Phosphate
  • Drug: Celecoxib
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 20, 2005)
28
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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:

Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00218205
Other Study ID Numbers  ICMJE K-EPIRU-0030-280-US
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Department of Veterans Affairs, New Jersey
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Basil Kasimis, MDDepartment of Veterans Affairs NJ Health Care System
PRS Account Department of Veterans Affairs, New Jersey
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP