Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00513071 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC) |
Estimated Enrollment: | 40 |
Study Start Date: | August 2007 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable and meeting 1 of the following criteria:
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):
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
Must be surgically or medically castrated
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Patients with any of the following conditions that impair the ability to swallow AZD0530 tablets:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Use of specifically prohibited CYP3A4-active agents or substances
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 |
Study Chair: | Primo N. Lara, MD | University of California, Davis |
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 |
recurrent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Hormones Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |