Phase II Study of AZD2171 in Patients With Malignant Tunica Vaginalis Mesothelioma

Phase II Study of AZD2171 in Patients With Malignant Pleural, Peritoneal, or Tunica Vaginalis Mesothelioma That is Not Amenable to Curative Surgery
Last Modified: 4/6/2009 First Published: 3/24/2006

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

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.

Outcomes

Primary Outcome(s)
Objective response rate (complete or partial response)

Secondary Outcome(s)
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

 

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

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