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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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00096304
Enrollment
36
Registered
2004-11-09
Start date
2004-06-08
Completion date
2007-11-30
Last updated
2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

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.

Interventions

DRUGdocetaxel
DRUGepirubicin hydrochloride

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026