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

This study has been completed.
Sponsor:
Information provided by:
Antisoma Research
ClinicalTrials.gov Identifier:
NCT00111618
First received: May 24, 2005
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: AS1404 (DMXAA)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Phase II Study of AS1404 in Combination With Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Antisoma Research:

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

Estimated Enrollment: 70
Study Start Date: May 2005
Study Completion Date: August 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111618

  Show 27 Study Locations
Sponsors and Collaborators
Antisoma Research
Investigators
Principal Investigator: Roberto Pili, MD The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00111618     History of Changes
Obsolete Identifiers: NCT00119275
Other Study ID Numbers: AS1404-203
Study First Received: May 24, 2005
Last Updated: January 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Antisoma Research:
vascular disrupting agent
safety
tolerability
efficacy
hormone refractory prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Vadimezan
Docetaxel
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014