Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer

NCT00096304 | Terminated Phase 1 DMC FDA Drug

• 4 other identifiers: MUSC-100781CDR0000378045MUSC-HR-11325AVENTIS-MUSC-100781
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Interventions

docetaxel DRUG

epirubicin hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Epirubicin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Andrew S. Kraft, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Gustavo Leone

  Medical University of South Carolina, Hollings Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: June 8, 2004
• Primary Completion: September 6, 2006
• Study Completion: November 30, 2007
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

US (1)