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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111618
• Other study ID #: AS1404-203
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2005
• Last updated: January 29, 2009
• Start date: May 2005
• Est. completion date: August 2008

Study information

• Verified date: January 2009
• Source: Antisoma Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Other known NCT identifiers

• NCT00119275

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• AS1404 (DMXAA)

Locations

Country	Name	City	State
United States	Central Hematology Oncology Medical Group Inc	Alhambra	California
United States	Peachtree Hematology and Oncology	Atlanta	Georgia
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Biomedical Research Alliance of New York (BRANY)	Bronx,	New York
United States	Providence Saint Joseph's Medical Center (PSJMC)	Burbank	California
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Pacific Oncology & Hematology Associates	Encinitas	California
United States	Virginia K. Crosson Cancer Center	Fullerton	California
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Pacific Shores Medical Group	Long Beach	California
United States	UCLA Clinical Research Unit	Los Angeles	California
United States	Marshfield Clinic Foundation	Marshfield	Wisconsin
United States	University of Miami School of Medicine	Miami	Florida
United States	Ochsner Cancer Institute	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	North Valley Hematology/Oncology Medical Group, The Thomas and Dorothy Leavey Cancer Center	Northridge	California
United States	Ventura County Hematology-Oncology Specialists	Oxnard	California
United States	Oncology Hematology Associates of Central Illinois,PC	Peoria	Illinois
United States	Cancer Care Associates Medical Group, Inc	Redondo Beach	California
United States	Sansum Santa Barbara Medical Foundation Clinic	Santa Barbara	California
United States	Santa Barbara Hematology Oncology Medical Group, Inc.	Santa Barbara	California
United States	Central Coast Medical Oncology Corporation	Santa Maria	California
United States	Park Nicollet Institute	St Louis Park	Minnesota
United States	Stanford University Medical Center-Cancer Center	Stanford	California
United States	Staten Island Urological Research	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Antisoma Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory safety
Primary	Adverse event monitoring
Primary	Electrocardiogram (EKG)
Primary	Ophthalmic assessments
Primary	Tumor assessment
Primary	Time to progression and survival time
Primary	Prostate-specific antigen (PSA)
Primary	Pharmacokinetic sampling