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Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
docetaxel
epirubicin hydrochloride
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hollings Cancer Center at Medical University of South Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 9, 2004
Last Updated
April 6, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00096304
Brief Title
Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Official Title
Phase I Trial of Epirubicin and Taxotere in Patients With Metastatic Androgen Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
June 8, 2004 (Actual)
Primary Completion Date
September 6, 2006 (Actual)
Study Completion Date
November 30, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew S. Kraft, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gustavo Leone
Organizational Affiliation
Medical University of South Carolina, Hollings Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer

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