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Phase I Trial of Epirubicin and Taxotere in Patients With Metastatic Androgen Independent Prostate Cancer

Phase 1
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase I Trial of Epirubicin and Taxotere in Patients With Metastatic Androgen Independent 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.

Inclusion Criteria


- 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

- 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

- 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

- No concurrent palliative radiotherapy


- See Disease Characteristics

- At least 4 weeks since prior surgery and recovered

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Andrew S. Kraft, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina


United States: Federal Government

Study ID:




Start Date:

June 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425