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

January 29, 2009 updated by: Antisoma Research

An Open Label, Randomized, Phase II Study of AS1404 in Combination With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Alhambra, California, United States, 91801
        • Central Hematology Oncology Medical Group Inc
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood And Cancer Center
      • Burbank, California, United States, 91505
        • Providence Saint Joseph's Medical Center (PSJMC)
      • Encinitas, California, United States, 92024
        • Pacific Oncology & Hematology Associates
      • Fullerton, California, United States, 92835
        • Virginia K. Crosson Cancer Center
      • Long Beach, California, United States, 90813-3244
        • Pacific Shores Medical Group
      • Los Angeles, California, United States, 90095
        • UCLA Clinical Research Unit
      • Northridge, California, United States, 91328
        • North Valley Hematology/Oncology Medical Group, The Thomas and Dorothy Leavey Cancer Center
      • Oxnard, California, United States, 93030
        • Ventura County Hematology-Oncology Specialists
      • Redondo Beach, California, United States, 90277
        • Cancer Care Associates Medical Group, Inc
      • Santa Barbara, California, United States, 93105
        • Sansum Santa Barbara Medical Foundation Clinic
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Hematology Oncology Medical Group, Inc.
      • Santa Maria, California, United States, 93454
        • Central Coast Medical Oncology Corporation
      • Stanford, California, United States, 94305
        • Stanford University Medical Center-Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Peachtree Hematology and Oncology
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Oncology Hematology Associates of Central Illinois,PC
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Cancer Institute
    • Maryland
      • Baltimore, Maryland, United States, 21231-1000
        • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Minnesota
      • St Louis Park, Minnesota, United States, 55416
        • Park Nicollet Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Bronx,, New York, United States, 10461
        • Biomedical Research Alliance of New York (BRANY)
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Staten Island, New York, United States, 10304
        • Staten Island Urological Research
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antisoma Research

Investigators

  • Principal Investigator: Roberto Pili, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

May 24, 2005

First Submitted That Met QC Criteria

May 24, 2005

First Posted (ESTIMATE)

May 25, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS1404-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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