Clinical Trial for Mesothelioma of the Tunica Vaginalis

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.