DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

NCT00024414 | Unknown Phase 2

• 4 other identifiers: CDR0000068930THERADEX-P01-00-04JHOC-01011003PROTARGA-P01-00-04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

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.

Conditions

Prostate Cancer

Keywords

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

Interventions

DHA-paclitaxel DRUG

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Theradex: lead

Study Sites (8)

Arizona Oncology Associates

Tucson, Arizona, 85712-2254, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Lucille Parker Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536-0098, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07019, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

docosahexaenoyl-paclitaxel

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael A. Carducci, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Last Updated: July 24, 2008

Record last verified: 2003-03

Locations

US (8)