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AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
This study has been completed.
First Received: August 6, 2007   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00513071
  Purpose

RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy.


Condition Intervention Phase
Prostate Cancer
Drug: AZD0530
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: AZD0530
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • PSA response rate (i.e., a 30% reduction and greater than or equal to a 50% reduction in the PSA level from baseline) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival compared to historical controls [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2007
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA) response rate and progression-free survival (PFS) in comparison with historical controls for patients with hormone-refractory prostate cancer (HRPC).
  • Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530.
  • Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population.

OUTLINE: This is a multicenter study.

Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for the first 2 years and then yearly thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable and meeting 1 of the following criteria:

    • No prior chemotherapy and relatively minimal cancer spread
    • Only one prior taxane-based chemotherapy for aggressive and/or symptomatic disease
  • Must have prostate cancer considered to be hormone refractory or androgen independent by one or more of the following criteria (despite androgen deprivation and anti-androgen withdrawal when applicable):

    • Progression of unidimensionally measurable disease assessed within 28 days prior to initial administration of drug
    • Progression of evaluable but not measurable disease assessed within 28 days prior to initial administration of drug for PSA evaluation and within 42 days for imaging studies (e.g., bone scans)
  • Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and non-target lesions (e.g., PSA level) assessed within 28 days prior to initial administration of drug

    • Measurable disease is not required but is allowed
  • Must be surgically or medically castrated

    • If the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin), then the patient must be willing to continue the use of LHRH agonists
    • Serum testosterone must be at castrate levels (< 50 ng/dL) at least 3 months prior to registration

Exclusion criteria:

  • Known brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-2
  • WBC ≥ 3,000/μL
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Hemoglobin > 9 g/dL
  • Total bilirubin within normal institutional limits
  • AST/ALT ≤ 2.5 x institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min
  • Must agree to use adequate contraception prior to study entry and for the duration of study participation

Exclusion criteria:

  • History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
  • Patients with any of the following conditions that impair the ability to swallow AZD0530 tablets:

    • Gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation
    • Prior surgical procedures affecting absorption
    • Active peptic ulcer disease
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • See Disease Characteristics
  • At least 3 weeks since the completion of chemotherapy and radiotherapy and the patient must have recovered from the side effects of the therapy
  • At least 28 days since prior non-steroidal anti-androgens (e.g., flutamide) (42 days for bicalutamide or nilutamide) or hormonal treatment (e.g., ketoconazole) and demonstrated progression of disease since the agents were suspended
  • Concurrent bisphosphonate therapy is allowed

Exclusion criteria:

  • Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Use of specifically prohibited CYP3A4-active agents or substances

    • Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
  • Patients receiving any other investigational agents
  • No investigational or commercial agents or therapies other than study drugs may be administered with the intent to treat the patient's malignancy
  • HIV-positive patients on combination antiretroviral therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513071

Locations
United States, California
City of Hope Medical Group
Pasadena, California, United States, 91105
Contra Costa Regional Medical Center
Martinez, California, United States, 94553
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
United States, Illinois
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615-7828
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, Missouri
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
California Cancer Consortium
Investigators
Study Chair: Primo N. Lara, MD University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: University of California Davis Cancer Center ( David R. Gandara )
Study ID Numbers: CDR0000559142, CCC-PHII-79, CHNMC-PHII-79
Study First Received: August 6, 2007
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00513071     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009