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AZD2171 in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
This study has been completed.

First Received on March 29, 2006.   Last Updated on March 7, 2012   History of Changes
Sponsor: University of Chicago
Collaborator: 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
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective response rate (complete or partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in laboratory correlates [ Designated as safety issue: No ]
  • Pharmacogenomics by correlating genetic polymorphisms with drug activity and toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2005
Primary Completion Date: September 2010 (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
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211-1850
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Contra Costa Regional Medical Center
Martinez, California, United States, 94553
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615-7828
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
United States, Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Michigan
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
United States, Pennsylvania
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Hedy L. Kindler, MD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: Everett E. Vokes, University of Chicago Cancer Research Center
ClinicalTrials.gov Identifier: NCT00309946     History of Changes
Other Study ID Numbers: CDR0000463521, UCCRC-14203B, NCI-7103
Study First Received: March 29, 2006
Last Updated: March 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
sarcomatous mesothelioma
epithelial mesothelioma
stage II malignant mesothelioma
stage III malignant mesothelioma
stage IV malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on May 24, 2012