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AZD2171 in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2007
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00309946
  Purpose

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

MedlinePlus related topics: Cancer Mesothelioma
Drug Information available for: Cediranib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma

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

Estimated Enrollment: 50
Study Start Date: December 2005
Estimated Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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.

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.

  Eligibility

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

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309946

Locations
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        
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Hedy L. Kindler, MD University of Chicago
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
sarcomatous mesothelioma
advanced malignant mesothelioma
epithelial mesothelioma
recurrent malignant mesothelioma
localized malignant mesothelioma

Study placed in the following topic categories:
Mesothelioma
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on January 14, 2009