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Prostate CancerPhase 2NCT00111618

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

A Phase 2 study testing AS1404 (DMXAA) in people with Prostate Cancer, run by Antisoma Research at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
AS1404 (DMXAA)
How many people
70 participants
Where
27 sitesUnited States
Study dates
May 2005to Aug 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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)
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  • 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)

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Central Hematology Oncology Medical Group Inc

    Alhambra, California, 91801

  • Peachtree Hematology and Oncology

    Atlanta, Georgia, 30309

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-1000

  • Providence Saint Joseph's Medical Center (PSJMC)

    Burbank, California, 91505

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Pacific Oncology & Hematology Associates

    Encinitas, California, 92024

  • Virginia K. Crosson Cancer Center

    Fullerton, California, 92835

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Pacific Shores Medical Group

    Long Beach, California, 90813-3244

  • UCLA Clinical Research Unit

    Los Angeles, California, 90095

  • Marshfield Clinic Foundation

    Marshfield, Wisconsin, 54449

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Ochsner Cancer Institute

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

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

    Northridge, California, 91328

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • Oncology Hematology Associates of Central Illinois,PC

    Peoria, Illinois, 61615

  • Cancer Care Associates Medical Group, Inc

    Redondo Beach, California, 90277

  • Park Nicollet Institute

    Saint Louis Park, Minnesota, 55416

  • Sansum Santa Barbara Medical Foundation Clinic

    Santa Barbara, California, 93105

  • Santa Barbara Hematology Oncology Medical Group, Inc.

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • Stanford University Medical Center-Cancer Center

    Stanford, California, 94305

  • Staten Island Urological Research

    Staten Island, New York, 10304

  • Biomedical Research Alliance of New York (BRANY)

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Being tested
AS1404 (DMXAA)
Keywords
vascular disrupting agent, safety, tolerability, efficacy, hormone refractory prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AS1404 (DMXAA)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Laboratory safety

  2. Adverse event monitoring

  3. Electrocardiogram (EKG)

  4. Ophthalmic assessments

  5. Tumor assessment

  6. Time to progression and survival time

  7. Prostate-specific antigen (PSA)

  8. Pharmacokinetic sampling

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionJun 2007
  4. Study completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111618
Sponsor's protocol ID
AS1404-203
Status last verified
Jan 2009
First submitted
24 May 2005
Last updated
30 Jan 2009
Results posted
No

Publications

  • 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.

    PubMed 12799625

  • 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.

    PubMed 17356709

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AS1404 (DMXAA) in people with Prostate Cancer, run by Antisoma Research at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Laboratory safety. The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00111618, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2009.

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