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AZD 2171 Clinical Trial

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
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
 

Alternate Title

AZD2171 in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery

 

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

 
Biomarker/Laboratory analysis, Treatment

 
Active

 
18 and over

 
NCI

 
UCCRC-14203B
NCI-7103, 7103, NCT00309946

 

Objectives

Primary

  1. 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

  1. Determine the progression-free survival of patients treated with AZD2171.
  2. Determine the toxicity experienced by patients treated with AZD2171.
  3. Determine median and overall survival of patients treated with AZD2171.

Tertiary

  1. 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

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
  
 
Canada
Ontario
 Toronto
 
 
 
 Princess Margaret Hospital
 
 Natasha Leighl, MD, FRCPC
Ph: 416-946-4645
  
 

 

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.



Table of Links

1http://clinicaltrials.gov/ct/show/NCT00309946