Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer

NCT ID: NCT00096304

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-08
• Study Completion Date: 2007-11-30

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

docetaxel

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew S. Kraft, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Gustavo Leone

Role: STUDY_CHAIR

Medical University of South Carolina, Hollings Cancer Center

Locations

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

CDR0000378045

Identifier Type: REGISTRY

Identifier Source: secondary_id

MUSC-HR-11325

Identifier Type: -

Identifier Source: secondary_id

AVENTIS-MUSC-100781

Identifier Type: -

Identifier Source: secondary_id

MUSC-100781

Identifier Type: -

Identifier Source: org_study_id