DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00024414
• Other study ID #: CDR0000068930
• Secondary ID: THERADEX-P01-00-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 13, 2001
• Last updated: July 23, 2008
• Start date: April 2001

Study information

• Verified date: March 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• DHA-paclitaxel

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	Lucille Parker Markey Cancer Center, University of Kentucky	Lexington	Kentucky
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	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana
United States	Arizona Oncology Associates	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Theradex

Country where clinical trial is conducted

United States,