Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
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

A total of 50 patients will be accrued for this study.

Outcomes

Objective response rate (complete or partial response)

Changes in laboratory correlates
Pharmacogenomics by correlating genetic polymorphisms with drug activity and toxicity

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

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
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	South Pasadena
	City of Hope Medical Group
		Mark McNamara, MD	Ph:  626-396-2900
			Email: mmcnamara@ccsmg.com
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 Hospital
		Clinical Trials Office - 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:  416-946-2399

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
Date Submitted to PDQ		2005-12-09
Information Last Verified		2007-06-03
NCI Grant/Contract Number		CM17102, CA14599

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