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 : Completed
First Posted : November 9, 2004
Last Update Posted : December 5, 2008
Information provided by:
National Cancer Institute (NCI)

November 9, 2004
November 9, 2004
December 5, 2008
June 2004
March 2008   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00096304 on Archive Site
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Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Phase I Trial of Epirubicin and Taxotere in Patients With Metastatic Androgen Independent Prostate Cancer

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.



  • Determine the maximum tolerated dose of epirubicin when administered with docetaxel in patients with metastatic, androgen-independent adenocarcinoma of the prostate.
  • Determine the response rate (objective and prostate-specific antigen response) and duration of response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of epirubicin.

Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of epirubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 18 months.

Phase 1
Primary Purpose: Treatment
Prostate Cancer
  • Drug: docetaxel
  • Drug: epirubicin hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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March 2008   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Medical University of South Carolina
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Principal Investigator: Andrew S. Kraft, MD Medical University of South Carolina
National Cancer Institute (NCI)
November 2008

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