Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: epirubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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) PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic 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 Renal Creatinine ≤ 1.5 times ULN Cardiovascular 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 Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy 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 Radiotherapy 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 Surgery See Disease Characteristics At least 4 weeks since prior surgery and recovered

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: epirubicin hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer