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Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00096304
Recruitment Status : Terminated (Low accrual)
First Posted : November 9, 2004
Last Update Posted : April 10, 2018
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as epirubicin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of epirubicin when given with docetaxel in treating patients with metastatic prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: docetaxel Drug: epirubicin hydrochloride Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Primary Purpose: Treatment
Official Title: Phase I Trial of Epirubicin and Taxotere in Patients With Metastatic Androgen Independent Prostate Cancer
Actual Study Start Date : June 8, 2004
Actual Primary Completion Date : September 6, 2006
Actual Study Completion Date : November 30, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate
  • Meets 1 of the following criteria:

    • Measurable disease with any prostate-specific antigen (PSA) value

      • Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
      • Histologic confirmation required if measurable disease is confined to a solitary lesion
    • Non-measurable disease with PSA ≥ 5 ng/mL*

      • The following are considered non-measurable disease:

        • Bone lesions
        • Pleural or pericardial effusion
        • Ascites
        • CNS lesions
        • Leptomeningeal disease
        • Irradiated lesions unless disease progression was documented after prior radiotherapy NOTE: *Patients with PSA ≥ 5 ng/mL only are not eligible
  • Progressive systemic disease despite ≥ 1 prior standard endocrine therapy with orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist, or diethylstilbestrol, as indicated by 1 of the following criteria:

    • Objective evidence of increase > 20% in the sum of the longest diameters of target lesions from the time of maximal regression OR the appearance of 1 or more new lesions
    • One or more new lesions on bone scan secondary to prostate cancer AND PSA ≥ 5 ng/mL
    • Elevated PSA (≥ 5 ng/mL) with 2 consecutive increases from baseline (taken ≥ 1 week apart)
  • Serum testosterone ≤ 50 ng/dL for patients without bilateral orchiectomy

    • Patients who have not had a bilateral orchiectomy should continue therapy with primary testicular androgen suppression (e.g., LHRH analogues)



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Meets 1 of the following criteria:

    • AST or ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
    • AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
    • AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal
  • Bilirubin normal


  • Creatinine ≤ 1.5 times ULN


  • No uncontrolled high blood pressure
  • No unstable angina
  • No symptomatic congestive heart failure
  • No myocardial infarction within the past 6 months
  • No serious uncontrolled cardiac arrhythmia
  • No New York Heart Association class III or IV heart disease


  • Fertile patients must use effective contraception during and for at least 3 months after study participation
  • No peripheral neuropathy ≥ grade 2
  • No prior severe hypersensitivity reaction to docetaxel or other drug formulated with polysorbate 80


Biologic therapy

  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)


  • No prior chemotherapy, including estramustine or suramin for prostate cancer
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior antiandrogen therapy
  • No concurrent hormonal therapy except steroids for adrenal insufficiency, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
  • No concurrent palliative radiotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior surgery and recovered

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00096304

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United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
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Principal Investigator: Andrew S. Kraft, MD Medical University of South Carolina
Study Chair: Gustavo Leone Medical University of South Carolina, Hollings Cancer Center
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Responsible Party: Medical University of South Carolina Identifier: NCT00096304    
Other Study ID Numbers: MUSC-100781
CDR0000378045 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medical University of South Carolina:
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors