- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00096304
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Principal Investigator: Andrew S. Kraft, MD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Docetaxel
- Epirubicin
Other Study ID Numbers
- MUSC-100781
- CDR0000378045 (Registry Identifier: PDQ (Physician Data Query))
- MUSC-HR-11325
- AVENTIS-MUSC-100781
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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