Phase II Study of AZD2171 in Patients With Malignant Pleural, Peritoneal, or Tunica Vaginalis Mesothelioma That is Not Amenable to Curative Surgery
Last Modified: 5/13/2008 First Published: 3/24/2006
Alternate Title
AZD2171 in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
Basic Trial Information
Phase II
Biomarker/Laboratory analysis, Treatment
Active
18 and over
NCI
Protocol ID numbers: UCCRC-14203B, NCI-7103, 7103, NCT00309946
Objectives
Primary
Determine the objective response rate in patients with malignant pleural, peritoneal, or tunica vaginalis mesothelioma that is not amenable to curative surgery who are treated with AZD2171.
Secondary
Determine the progression-free survival of patients treated with AZD2171.
Determine the toxicity experienced by patients treated with AZD2171.
Determine median and overall survival of patients treated with AZD2171.
Tertiary
Generate preliminary data regarding potential utility of pharmacogenomic and plasma/serum biomarkers of angiogenesis as predictive or prognostic markers for future investigations of this drug in malignant mesothelioma.
Entry Criteria
Disease Characteristics:
Histologically or cytologically confirmed malignant pleural, peritoneal, or tunica vaginalis mesothelioma
Epithelial, sarcomatoid, or mixed subtype
International Mesothelioma Interest Group stage II-IV disease (for patients with pleural mesothelioma)
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan
Pleural effusion and ascites are not considered measurable lesions
Disease not amenable to curative surgery
No known brain metastases
Prior/Concurrent Therapy:
No more than 1 prior cytotoxic chemotherapy
Prior intrapleural cytotoxic agents (including bleomycin) do not count towards prior cytotoxic chemotherapy
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
No prior radiotherapy to the only site of measurable disease
At least 4 weeks since prior radiotherapy and recovered
At least 4 weeks since prior major surgery and recovered
More than 30 days since prior participation in an investigational trial
No prior treatment with a vascular endothelial growth factor (VEGF) inhibitor
No other concurrent investigational agents
No concurrent commercial agents for the malignancy
No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, or pentamidine)
No concurrent hematopoietic growth factors except epoetin alfa
No concurrent palliative radiotherapy
No combination antiretroviral therapy for HIV-positive patients
No concurrent drugs or biologics with proarrhythmic potential
Patient Characteristics:
ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
Life expectancy > 3 months
WBC ≥ 3,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Hemoglobin ≥ 8 g/dL
Platelets ≥ 100,000/mm³
Total bilirubin normal
AST/ALT ≤ 2.5 times upper limit of normal (ULN)
Creatinine normal OR creatinine clearance > 60 mL/min
Fertile patients must use effective contraception
Not pregnant or nursing
Negative pregnancy test
No history of allergic reactions to compounds of similar chemical or biologic composition to AZD2171
Mean QTc ≤ 500 msec (with Bazett’s correction) by EKG
No history of long QT syndrome
Proteinuria ≤ 1+ on two consecutive dipsticks taken ≥ 1 week apart
No other concurrent malignancy
No New York Heart Association class III or IV cardiac disease
No uncontrolled intercurrent illness including, but not limited to, any of the following:
Hypertension
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness or social situations that would limit study compliance
Expected Enrollment: 50
A total of 50 patients will be accrued for this study.
Outline of Study
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.
Trial Contact Information
Trial Lead Organizations
University of Chicago Cancer Research Center
Hedy Kindler, MD, Principal investigator Ph: 773-702-0360; 888-824-0200
Trial Sites
U.S.A.
California
Beverly Hills
Tower Cancer Research Foundation
Philomena McAndrew, MD Ph: 310-888-8680
Duarte
City of Hope Comprehensive Cancer Center
Clinical Trials Office - City of Hope Comprehensive Cancer Center Ph: 800-826-4673
Email: becomingapatient@coh.org
Los Angeles
USC/Norris Comprehensive Cancer Center and Hospital
Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital Ph: 323-865-0451
Martinez
Contra Costa Regional Medical Center
Sharon Hiner, MD Ph: 925-370-5114
800-232-4636
Email: shiner@hsd.co.contra-costa.ca.us
Pasadena
City of Hope Medical Group
Mark McNamara, MD Ph: 626-396-2900
Email: mmcnamara@ccsmg.com
Sacramento
University of California Davis Cancer Center
Clinical Trials Office - University of California Davis Cancer Center Ph: 916-734-3089
Illinois
Chicago
University of Chicago Cancer Research Center
Clinical Trials Office - University of Chicago Cancer Research Center Ph: 773-834-7424
Decatur
Decatur Memorial Hospital Cancer Care Institute
Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute Ph: 217-876-6601
Evanston
Evanston Northwestern Healthcare - Evanston Hospital
Clinical Trials Office - Evanston Northwestern Healthcare - Evanston Hospital Ph: 847-570-1381
Harvey
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital Ph: 708-915-6747
Maywood
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Clinical Trials Office - Cardinal Bernardin Cancer Center Ph: 708-226-4357
Peoria
Oncology Hematology Associates of Central Illinois, PC - Peoria
Sachdev Thomas, MD Ph: 309-243-1000
Email: sthomas@ohaci.com
Springfield
Central Illinois Hematology Oncology Center
Edem Agamah, MD, MS Ph: 217-525-2500
Email: ihdn@aol.com
Indiana
Fort Wayne
Fort Wayne Medical Oncology and Hematology
David Sciortino, MD Ph: 260-484-8830
800-852-2333
South Bend
CCOP - Northern Indiana CR Consortium
David Taber, MD Ph: 574-647-3353
800-284-7370
Michigan
Saint Joseph
Oncology Care Associates, PLLC
Eric Lester, MD Ph: 269-985-0029
Pennsylvania
Hershey
Penn State Cancer Institute at Milton S. Hershey Medical Center
Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center Ph: 717-531-3779
Email: CTO@hmc.psu.edu
Wisconsin
Milwaukee
Medical College of Wisconsin Cancer Center
Clinical Trials Office - Medical College of Wisconsin Cancer Center Ph: 414-805-4380
Registry Information
Official Title Phase II Study of AZD2171 (NSC#732208) in Patients with Malignant Mesothelioma
Trial Start Date 2005-12-05
Trial Completion Date 2006-10-01 (estimated)
Registered in ClinicalTrials.gov NCT00309946 1
Date Submitted to PDQ 2005-12-09
Information Last Verified 2007-06-03
NCI Grant/Contract Number CM17102, CA14599
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.