RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of malignant mesothelioma. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have malignant mesothelioma...
Date First Received: October 11, 2001
Last Updated: April 8, 2008
Verified by: National Cancer Institute (NCI), September 2006
Clinical Trial Phase: Phase 2 | Start Date: August 2001
Overall Status: Completed
Brief Summary
Official Title: “A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma”
Condition Keyword(s):
Intervention(s):
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of malignant mesothelioma.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have malignant mesothelioma.
Study Type: Interventional
Study Design: Treatment
Detailed Clinical Trial Description
OBJECTIVES: - Determine the activity of gefitinib, in terms of failure-free survival, in patients with malignant mesothelioma. - Determine the response rate in patients treated with this drug. - Determine the toxicity of this drug in these patients. - Determine the overall survival of patients treated with this drug. - Determine whether overexpression of epidermal growth factor receptor and expression of cyclo-oxygenase-2 can predict the effectiveness of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 7-10 months.
Criteria for Participation in this Clinical Trial
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant mesothelioma that is not amenable to curative surgery or radiotherapy
- Epithelial, sarcomatoid, or mixed subtype
- Any site of origin (including, but not limited to, the pleura, peritoneum, pericardium, or tunica vaginalis) allowed
- Measurable disease, defined as lesions that can be accurately measured in at least 1 dimension (longest diameter) as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
- Must be outside prior radiation port
- Lesions not considered measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- CTC 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other concurrent active malignancy except nonmelanoma skin cancer
- Disease considered not currently active if completely treated with less than a 30% risk for relapse
- No other concurrent uncontrolled illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior epidermal growth factor receptor-inhibitor therapy
Chemotherapy:
- Prior intrapleural cytotoxic or sclerosing agents (including bleomycin) allowed
- No prior systemic cytotoxic chemotherapy for malignant mesothelioma
- No concurrent chemotherapy
Endocrine therapy:
- At least 1 week since prior CYP3A4 inducers (e.g., dexamethasone, glucocorticoids, progesterone)
- No concurrent CYP3A4 inducers (e.g., dexamethasone)
- No concurrent hormonal therapy (e.g., tamoxifen) except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy, including for palliation
Surgery:
- See Disease Characteristics
- At least 2 weeks since prior major surgery
Other:
- At least 1 week since other prior CYP3A4 inducers (e.g., carbamazepine, ethosuximide, griseofulvin, nafcillin, nelfinavir mesylate, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rofecoxib, St. John's Wort, sulfadimidine, sulfinpyrazone, or troglitazone)
- No other concurrent CYP3A4 inducers
- No concurrent CYP3A4 substrates or inhibitors
- No other concurrent investigational agent
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent chlorpromazine, amiodarone, or chloroquine
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Cancer and Leukemia Group B
Veterans Affairs Medical Center - Birmingham
Birmingham Alabama 35233-1996 United States
Cedars-Sinai Medical Center
Los Angeles California 90048 United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California 94143-0128 United States
University of California San Diego Cancer Center
La Jolla California 92093-0658 United States
Veterans Affairs Medical Center - San Francisco
San Francisco California 94121 United States
CCOP - Christiana Care Health Services
Wilmington Delaware 19899 United States
Lombardi Cancer Center
Washington District of Columbia 20007 United States
Walter Reed Army Medical Center
Washington District of Columbia 20307-5000 United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida 33140 United States
University of Chicago Cancer Research Center
Chicago Illinois 60637-1470 United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois 60612 United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana 46601 United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City Iowa 52242-1009 United States
Veterans Affairs Medical Center - Togus
Togus Maine 04330 United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore Maryland 21201 United States
Dana-Farber Cancer Institute
Boston Massachusetts 02115 United States
University of Massachusetts Memorial Medical Center
Worcester Massachusetts 01655 United States
University of Minnesota Cancer Center
Minneapolis Minnesota 55455 United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota 55417 United States
Barnes-Jewish Hospital
Saint Louis Missouri 63110 United States
Ellis Fischel Cancer Center - Columbia
Columbia Missouri 65203 United States
Missouri Baptist Cancer Center
Saint Louis Missouri 63131 United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia Missouri 65201 United States
Washington University Siteman Cancer Center
Saint Louis Missouri 63110 United States
University of Nebraska Medical Center
Omaha Nebraska 68198-3330 United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada 89106 United States
Norris Cotton Cancer Center
Lebanon New Hampshire 03756-0002 United States
CCOP - North Shore University Hospital
Manhasset New York 11030 United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse New York 13217 United States
Memorial Sloan-Kettering Cancer Center
New York New York 10021 United States
Mount Sinai Medical Center, NY
New York New York 10029 United States
New York Presbyterian Hospital - Cornell Campus
New York New York 10021 United States
Roswell Park Cancer Institute
Buffalo New York 14263-0001 United States
Schneider Children's Hospital at North Shore
Manhasset New York 11030 United States
State University of New York - Upstate Medical University
Syracuse New York 13210 United States
Veterans Affairs Medical Center - Buffalo
Buffalo New York 14215 United States
Veterans Affairs Medical Center - Syracuse
Syracuse New York 13210 United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina 27104-4241 United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina 27157-1082 United States
Duke Comprehensive Cancer Center
Durham North Carolina 27710 United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina 27599-7295 United States
Veterans Affairs Medical Center - Durham
Durham North Carolina 27705 United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio 43210-1240 United States
Western Pennsylvania Hospital
Pittsburgh Pennsylvania 15224 United States
Rhode Island Hospital
Providence Rhode Island 02903 United States
University of Tennessee, Memphis Cancer Center
Memphis Tennessee 38103 United States
Veterans Affairs Medical Center - Memphis
Memphis Tennessee 38104 United States
Green Mountain Oncology Group
Bennington Vermont 05201 United States
Vermont Cancer Center
Burlington Vermont 05401-3498 United States
Veterans Affairs Medical Center - White River Junction
White River Junction Vermont 05009 United States
MBCCOP - Massey Cancer Center
Richmond Virginia 23298-0037 United States
Veterans Affairs Medical Center - Richmond
Richmond Virginia 23249 United States
Overall Clinical Trial Officials and Contacts
Ramaswamy Govindan, MD Study Chair Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Related Publications
Citations Reporting Results
Govindan R, Kratzke RA, Herndon JE 2nd, Niehans GA, Vollmer R, Watson D, Green MR, Kindler HL; Cancer and Leukemia Group B (CALGB 30101). Gefitinib in patients with malignant mesothelioma: a phase II study by the Cancer and Leukemia Group B. Clin Cancer Res. 2005 Mar 15;11(6):2300-4.
Govindan R, Kratzke RA, Herndon JE, et al.: Gefitinib in patients with malignant mesothelioma (MM): a phase II study by the Cancer and Leukemia Group B (CALGB 30101). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2535, 630, 2003.
Additional Information
Information obtained from ClinicalTrials.gov on May 08, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00025207
Study ID Number: CDR0000068938
ClinicalTrials.gov Identifier: NCT00025207
Health Authority: United States: Federal Government
Clinical trial summary from the National Cancer Institute's PDQ® database
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
