DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

NCT ID: NCT00024414

Last Updated: 2008-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description

OBJECTIVES:

• Determine the objective tumor response rate or prostate-specific antigen response, duration of response, and time to disease progression in patients with metastatic hormone-refractory prostate cancer treated with DHA-paclitaxel.
• Determine the overall survival of patients treated with this drug.
• Determine the toxicity profile of this drug in these patients.
• Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 2 courses, and off study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-50 patients will be accrued for this study.

Conditions

Prostate Cancer

Keywords

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

DHA-paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the prostate

• Progressive metastatic disease on continuous hormonal therapy (e.g., orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist)
• Progressive disease is defined by all of the following:

• Measurable disease or lesions on bone scan
• Increases in prostate-specific antigen (PSA) levels on at least 2 consecutive measurements
• Continued PSA elevation after cessation of prior antiandrogen therapy (4 weeks after flutamide and nilutamide and 8 weeks after bicalutamide)
• PSA level at least 5 ng/mL
• Serum testosterone level less than 50 ng/mL

• Patients who have not undergone prior surgical castration should continue primary androgen suppression (LHRH agonist)
• No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled ventricular arrhythmia
• No myocardial infarction within the past 3 months
• No superior vena cava syndrome

Neurologic:

• No peripheral neuropathy greater than grade 1
• No uncontrolled major seizure disorder
• No spinal cord compression

Other:

• No psychiatric disorder that would preclude informed consent
• No unstable or serious concurrent medical condition
• No concurrent serious infection requiring parenteral therapy
• No other prior or concurrent malignancy except:

• Curatively treated nonmelanoma skin cancer OR
• Other cancer curatively treated with surgery alone that has not recurred for more than 5 years
• Fertile patients must use effective contraception during and for at least 6 months after study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior taxanes
• Prior mitoxantrone or prednisone for metastatic disease allowed
• At least 28 days since prior chemotherapy and recovered
• No other concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics
• No concurrent hormonal therapy

Radiotherapy:

• No prior samarium SM 153 lexidronam pentasodium or strontium chloride Sr 89
• Prior external radiotherapy for metastatic disease allowed
• At least 28 days since prior large-field radiotherapy and recovered
• No concurrent radiotherapy, including whole-brain radiotherapy for documented CNS metastasis

Surgery:

• See Disease Characteristics
• At least 14 days since prior major surgery and recovered

Other:

• No other prior nonhormonal treatment for metastatic disease
• At least 28 days since prior herbal preparations (e.g., PC-SPES) and recovered
• No other concurrent anticancer medications

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

Sponsors

Theradex

INDUSTRY

Sponsor Role: lead

Principal Investigators

Michael A. Carducci, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Arizona Oncology Associates

Tucson, Arizona, United States

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Lucille Parker Markey Cancer Center, University of Kentucky

Lexington, Kentucky, United States

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

THERADEX-P01-00-04

Identifier Type: -

Identifier Source: secondary_id

JHOC-01011003

Identifier Type: -

Identifier Source: secondary_id

PROTARGA-P01-00-04

Identifier Type: -

Identifier Source: secondary_id

CDR0000068930

Identifier Type: -

Identifier Source: org_study_id