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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00309946 |
RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well AZD2171 works in treating patients with malignant mesothelioma that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Malignant Mesothelioma |
Drug: cediranib maleate Procedure: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma |
Estimated Enrollment: | 50 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study.
Patients receive oral ADZ2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically during study for biomarker and optional pharmacogenomic correlative studies.
After completion of study treatment, patients are followed for up to 8 weeks.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant pleural, peritoneal, or tunica vaginalis mesothelioma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No more than 1 prior cytotoxic chemotherapy
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
City of Hope Medical Group | Recruiting |
Pasadena, California, United States, 91105 | |
Contact: Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com | |
Contra Costa Regional Medical Center | Recruiting |
Martinez, California, United States, 94553 | |
Contact: Sharon Hiner, MD 925-370-5114 shiner@hsd.co.contra-costa.ca.us | |
Tower Cancer Research Foundation | Recruiting |
Beverly Hills, California, United States, 90211-1850 | |
Contact: Philomena F. McAndrew, MD 310-888-8680 | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
Los Angeles, California, United States, 90089-9181 | |
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
Maywood, Illinois, United States, 60153 | |
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
Central Illinois Hematology Oncology Center | Recruiting |
Springfield, Illinois, United States, 62701 | |
Contact: Edem S. Agamah, MD, MS 217-525-2500 ihdn@aol.com | |
Decatur Memorial Hospital Cancer Care Institute | Recruiting |
Decatur, Illinois, United States, 62526 | |
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-6601 | |
Evanston Northwestern Healthcare - Evanston Hospital | Recruiting |
Evanston, Illinois, United States, 60201-1781 | |
Contact: Clinical Trials Office - Evanston Northwestern Healthcare - Ev 847-570-1381 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Recruiting |
Harvey, Illinois, United States, 60426 | |
Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls 708-915-6747 | |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Recruiting |
Peoria, Illinois, United States, 61615-7828 | |
Contact: Sachdev P. Thomas, MD 309-243-1000 sthomas@ohaci.com | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | Recruiting |
South Bend, Indiana, United States, 46601 | |
Contact: David A. Taber, MD 574-647-3353 | |
Fort Wayne Medical Oncology and Hematology | Recruiting |
Fort Wayne, Indiana, United States, 46885-5099 | |
Contact: David F. Sciortino, MD 260-484-8830 | |
United States, Michigan | |
Oncology Care Associates, PLLC | Recruiting |
Saint Joseph, Michigan, United States, 49085 | |
Contact: Eric P. Lester, MD 269-985-0029 | |
United States, Pennsylvania | |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033-0850 | |
Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 | |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Natasha Leighl, MD, FRCPC 416-946-4645 |
Principal Investigator: | Hedy L. Kindler, MD | University of Chicago |
Study ID Numbers: | CDR0000463521, UCCRC-14203B, NCI-7103 |
Study First Received: | March 29, 2006 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00309946 |
Health Authority: | Unspecified |
sarcomatous mesothelioma advanced malignant mesothelioma epithelial mesothelioma recurrent malignant mesothelioma localized malignant mesothelioma |
Mesothelioma Adenoma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Mesothelial |