Study of AS1404 With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

NCT00111618 | Completed Phase 2

• 1 other identifier: AS1404-203
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 27

Brief Summary

The purpose of this trial is to confirm a safe dose of AS1404, to be given with docetaxel, and to see whether adding AS1404 and docetaxel together improves the outcome of the treatment, when compared to docetaxel alone.

Conditions

Prostate Cancer

Keywords

vascular disrupting agent; safety; tolerability; efficacy; hormone refractory prostate cancer

Outcome Measures

Primary Outcomes (8)

• Laboratory safety

• Adverse event monitoring

• Electrocardiogram (EKG)

• Ophthalmic assessments

• Tumor assessment

• Time to progression and survival time

• Prostate-specific antigen (PSA)

• Pharmacokinetic sampling

Interventions

AS1404 (DMXAA) DRUG

Eligibility Criteria

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

You may qualify if:

• Age equal to, or greater than 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy greater than or equal to 3 months
• Histopathologically confirmed adenocarcinoma of the prostate
• Metastatic progressive androgen-independent prostate cancer with no previous chemotherapy treatment
• At least 4 weeks off of flutamide and 6 weeks off of bicalutamide and nilutamide
• Patients who have not undergone surgical castration must continue treatment with an luteinizing hormone-releasing hormone (LHRH) agonist. In those patients where, for some reason, the LHRH agonist has been discontinued prior to entry on the study, it should be reinstituted and disease progression must be documented.
• Hematological and biochemical indices at screening within the following ranges:
• An absolute neutrophil count of greater than or equal to 1.5 x 10\^9/L;
• A platelet count of greater than or equal to 100 x 10\^9/L;
• A hemoglobin level of greater than or equal to 10 g/dL.
• Adequate hepatic and renal function, as defined by:
• Serum bilirubin less than or equal to upper limit of normal (ULN);
• SGOT and/or SGPT less than or equal to 1.5 x ULN concomitant with alkaline phosphatase less than or equal to 2.5 x ULN;
• Serum creatinine less than or equal to 120 micromol/L or creatinine clearance greater than or equal to 60 mL/min.

You may not qualify if:

• Decreasing PSA levels after antiandrogen withdrawal
• Previous chemotherapy treatment for prostate cancer
• Patients who have received blood transfusions or growth factors to aid hematological recovery within two weeks of scheduled baseline visit
• Concurrent severe and/or uncontrolled co-morbid medical condition within 2 weeks of screening
• Previous exposure to AS1404 or other vascular targeting agents
• Clinically significant cardiac arrhythmias and known QTc prolongation (interval \>450 msec)
• Evidence of severe or uncontrolled systemic disease that, in the opinion of the Investigator, might interfere with the patient's participation in the study
• A history of alcoholism; drug addiction; or any psychiatric condition, which, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures
• A history of hypersensitivity to taxanes or other drugs formulated with polysorbate 80
• Treatment with the following medications within two weeks of AS1404 administration or the expected need for such treatments during the study period:
• Medications known to modulate serotonin;
• Medications known to affect the QT interval;
• Current treatment with, or the expected need during the treatment period for ketoconazole, erythromycin, troleandomycin, and/or cyclosporine. The use of other agents known to induce, inhibit, or that are metabolized by cytochrome P450-3A4 should be undertaken with caution.
• Concurrent or previous malignancy of a different tumor type within five years of starting the study, except for adequately treated non-melanoma skin cancer
• Clinical or radiological evidence of central nervous system (CNS) metastases

Sponsors & Collaborators

• Antisoma Research: lead

Study Sites (27)

Central Hematology Oncology Medical Group Inc

Alhambra, California, 91801, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Providence Saint Joseph's Medical Center (PSJMC)

Burbank, California, 91505, United States

Location

Pacific Oncology & Hematology Associates

Encinitas, California, 92024, United States

Location

Virginia K. Crosson Cancer Center

Fullerton, California, 92835, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813-3244, United States

Location

UCLA Clinical Research Unit

Los Angeles, California, 90095, United States

Location

North Valley Hematology/Oncology Medical Group, The Thomas and Dorothy Leavey Cancer Center

Northridge, California, 91328, United States

Location

Ventura County Hematology-Oncology Specialists

Oxnard, California, 93030, United States

Location

Cancer Care Associates Medical Group, Inc

Redondo Beach, California, 90277, United States

Location

Sansum Santa Barbara Medical Foundation Clinic

Santa Barbara, California, 93105, United States

Location

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, 93105, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

Stanford University Medical Center-Cancer Center

Stanford, California, 94305, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Peachtree Hematology and Oncology

Atlanta, Georgia, 30309, United States

Location

Oncology Hematology Associates of Central Illinois,PC

Peoria, Illinois, 61615, United States

Location

Ochsner Cancer Institute

New Orleans, Louisiana, 70121, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-1000, United States

Location

Park Nicollet Institute

Saint Louis Park, Minnesota, 55416, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Staten Island Urological Research

Staten Island, New York, 10304, United States

Location

Biomedical Research Alliance of New York (BRANY)

The Bronx, New York, 10461, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Marshfield Clinic Foundation

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (2)

• Jameson MB, Thompson PI, Baguley BC, Evans BD, Harvey VJ, Porter DJ, McCrystal MR, Small M, Bellenger K, Gumbrell L, Halbert GW, Kestell P; Phase I/II Trials Committee of Cancer Research UK. Clinical aspects of a phase I trial of 5,6-dimethylxanthenone-4-acetic acid (DMXAA), a novel antivascular agent. Br J Cancer. 2003 Jun 16;88(12):1844-50. doi: 10.1038/sj.bjc.6600992.

  PMID: 12799625 BACKGROUND

• Seshadri M, Spernyak JA, Maiery PG, Cheney RT, Mazurchuk R, Bellnier DA. Visualizing the acute effects of vascular-targeted therapy in vivo using intravital microscopy and magnetic resonance imaging: correlation with endothelial apoptosis, cytokine induction, and treatment outcome. Neoplasia. 2007 Feb;9(2):128-35. doi: 10.1593/neo.06748.

  PMID: 17356709 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

vadimezan

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

• Roberto Pili, MD

  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 24, 2005
• First Posted: May 25, 2005
• Study Start: May 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: August 1, 2008
• Last Updated: January 30, 2009

Record last verified: 2009-01

Locations

US (27)