Study of AS1404 With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer
NCT ID: NCT00111618
Last Updated: 2009-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2005-05-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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AS1404 (DMXAA)
Eligibility Criteria
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Inclusion Criteria
* 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.
* Be willing and able to provide written informed consent and, in the opinion of the Investigator, be able to comply with the study assessments and follow-up
* Serum testosterone no greater than 50 ng/mL (chemically castrated patients only)
Exclusion Criteria
* 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
* Symptomatic peripheral neuropathy greater than or equal to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade II
* Evidence of any other significant clinical disorder or laboratory finding that, in the opinion of the Investigator, compromises the patient safety during study participation
* Participation in any prostate cancer investigational drug study in which the study drug has not subsequently obtained a product license
* Any other concurrent treatment for prostate cancer (with the exception of palliative radiotherapy) other than that specified in the protocol, including the use of herbal remedies, (e.g. saw palmetto)
18 Years
MALE
No
Sponsors
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Antisoma Research
INDUSTRY
Principal Investigators
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Roberto Pili, MD
Role: PRINCIPAL_INVESTIGATOR
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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Central Hematology Oncology Medical Group Inc
Alhambra, California, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Providence Saint Joseph's Medical Center (PSJMC)
Burbank, California, United States
Pacific Oncology & Hematology Associates
Encinitas, California, United States
Virginia K. Crosson Cancer Center
Fullerton, California, United States
Pacific Shores Medical Group
Long Beach, California, United States
UCLA Clinical Research Unit
Los Angeles, California, United States
North Valley Hematology/Oncology Medical Group, The Thomas and Dorothy Leavey Cancer Center
Northridge, California, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Cancer Care Associates Medical Group, Inc
Redondo Beach, California, United States
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Stanford University Medical Center-Cancer Center
Stanford, California, United States
University of Miami School of Medicine
Miami, Florida, United States
Peachtree Hematology and Oncology
Atlanta, Georgia, United States
Oncology Hematology Associates of Central Illinois,PC
Peoria, Illinois, United States
Ochsner Cancer Institute
New Orleans, Louisiana, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Columbia University Medical Center
New York, New York, United States
Staten Island Urological Research
Staten Island, New York, United States
Biomedical Research Alliance of New York (BRANY)
The Bronx, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Marshfield Clinic Foundation
Marshfield, Wisconsin, United States
Countries
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References
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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.
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.
Other Identifiers
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AS1404-203
Identifier Type: -
Identifier Source: org_study_id
NCT00119275
Identifier Type: -
Identifier Source: nct_alias