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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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

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

- Previous exposure to AS1404 or other vascular targeting agents

- Clinically significant cardiac arrhythmias and known QTc prolongation (interval >450

- 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

- A history of hypersensitivity to taxanes or other drugs formulated with polysorbate

- 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 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Laboratory safety

Principal Investigator

Roberto Pili, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

August 2008

Related Keywords:

  • Prostate Cancer
  • vascular disrupting agent
  • safety
  • tolerability
  • efficacy
  • hormone refractory prostate cancer
  • Prostatic Neoplasms



Cleveland Clinic Foundation Cleveland, Ohio  44195
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Comprehensive Blood and Cancer Center Bakersfield, California  93309
Pacific Shores Medical Group Long Beach, California  90813
Ochsner Cancer Institute New Orleans, Louisiana  70121
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231
Virginia K. Crosson Cancer Center Fullerton, California  92835
Ventura County Hematology-Oncology Specialists Oxnard, California  93030
Santa Barbara Hematology Oncology Medical Group, Inc. Santa Barbara, California  93105
University of Miami School of Medicine Miami, Florida  33136
Peachtree Hematology and Oncology Atlanta, Georgia  40202
Staten Island Urological Research Staten Island, New York  10304
Columbia University Medical Center New York, New York  10032
University of Virginia Health System Charlottesville, Virginia  22903
Sansum Santa Barbara Medical Foundation Clinic Santa Barbara, California  93105
Central Hematology Oncology Medical Group Inc Alhambra, California  91801
Providence Saint Joseph's Medical Center (PSJMC) Burbank, California  91505
Pacific Oncology & Hematology Associates Encinitas, California  92024
UCLA Clinical Research Unit Los Angeles, California  90095
North Valley Hematology/Oncology Medical Group, The Thomas and Dorothy Leavey Cancer Center Northridge, California  91328
Cancer Care Associates Medical Group, Inc Redondo Beach, California  90277
Central Coast Medical Oncology Corporation Santa Maria, California  93454
Stanford University Medical Center-Cancer Center Stanford, California  94305
Oncology Hematology Associates of Central Illinois,PC Peoria, Illinois  61615
Park Nicollet Institute St Louis Park, Minnesota  55416
Biomedical Research Alliance of New York (BRANY) Bronx,, New York  10461
Marshfield Clinic Foundation Marshfield, Wisconsin  54449