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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AS1404 (DMXAA)
Sponsored by
Antisoma Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring vascular disrupting agent, safety, tolerability, efficacy, hormone refractory prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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. 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: 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 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)

Sites / Locations

  • Central Hematology Oncology Medical Group Inc
  • Comprehensive Blood and Cancer Center
  • Providence Saint Joseph's Medical Center (PSJMC)
  • Pacific Oncology & Hematology Associates
  • Virginia K. Crosson Cancer Center
  • Pacific Shores Medical Group
  • UCLA Clinical Research Unit
  • North Valley Hematology/Oncology Medical Group, The Thomas and Dorothy Leavey Cancer Center
  • Ventura County Hematology-Oncology Specialists
  • Cancer Care Associates Medical Group, Inc
  • Sansum Santa Barbara Medical Foundation Clinic
  • Santa Barbara Hematology Oncology Medical Group, Inc.
  • Central Coast Medical Oncology Corporation
  • Stanford University Medical Center-Cancer Center
  • University of Miami School of Medicine
  • Peachtree Hematology and Oncology
  • Oncology Hematology Associates of Central Illinois,PC
  • Ochsner Cancer Institute
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Park Nicollet Institute
  • Comprehensive Cancer Centers of Nevada
  • Biomedical Research Alliance of New York (BRANY)
  • Columbia University Medical Center
  • Staten Island Urological Research
  • Cleveland Clinic Foundation
  • University of Virginia Health System
  • Marshfield Clinic Foundation

Outcomes

Primary Outcome Measures

Laboratory safety
Adverse event monitoring
Electrocardiogram (EKG)
Ophthalmic assessments
Tumor assessment
Time to progression and survival time
Prostate-specific antigen (PSA)
Pharmacokinetic sampling

Secondary Outcome Measures

Full Information

First Posted
May 24, 2005
Last Updated
January 29, 2009
Sponsor
Antisoma Research
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1. Study Identification

Unique Protocol Identification Number
NCT00111618
Brief Title
Study of AS1404 With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer
Official Title
An Open Label, Randomized, Phase II Study of AS1404 in Combination With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Antisoma Research

4. Oversight

5. Study Description

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.
Detailed Description
The overall aim of this study is to determine the safety, tolerability and efficacy of AS1404 in combination with docetaxel in patients with hormone refractory metastatic prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
vascular disrupting agent, safety, tolerability, efficacy, hormone refractory prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AS1404 (DMXAA)
Primary Outcome Measure Information:
Title
Laboratory safety
Title
Adverse event monitoring
Title
Electrocardiogram (EKG)
Title
Ophthalmic assessments
Title
Tumor assessment
Title
Time to progression and survival time
Title
Prostate-specific antigen (PSA)
Title
Pharmacokinetic sampling

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Pili, MD
Organizational Affiliation
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Hematology Oncology Medical Group Inc
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Providence Saint Joseph's Medical Center (PSJMC)
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Pacific Oncology & Hematology Associates
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Virginia K. Crosson Cancer Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813-3244
Country
United States
Facility Name
UCLA Clinical Research Unit
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
North Valley Hematology/Oncology Medical Group, The Thomas and Dorothy Leavey Cancer Center
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
Ventura County Hematology-Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Cancer Care Associates Medical Group, Inc
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Sansum Santa Barbara Medical Foundation Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Santa Barbara Hematology Oncology Medical Group, Inc.
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Stanford University Medical Center-Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Peachtree Hematology and Oncology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois,PC
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Ochsner Cancer Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-1000
Country
United States
Facility Name
Park Nicollet Institute
City
St Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Biomedical Research Alliance of New York (BRANY)
City
Bronx,
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Staten Island Urological Research
City
Staten Island
State/Province
New York
ZIP/Postal Code
10304
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Marshfield Clinic Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12799625
Citation
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.
Results Reference
background
PubMed Identifier
17356709
Citation
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.
Results Reference
derived

Learn more about this trial

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

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