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Home > "Z" Clinical Trials Conditions > ZD 1839 in Treating Patients With Malignant Mesothelioma  ZD 1839 in Treating Patients With Malignant Mesothelioma
ZD 1839 in Treating Patients With Malignant Mesothelioma
For Condition: recurrent malignant mesothelioma,advanced malignant mesothelioma,epithelial mesothelioma,sarcomatous mesothelioma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Biological therapies such as ZD 1839 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 ZD 1839 in treating patients who have malignant mesothelioma.
Details: OBJECTIVES: I. Determine the activity of ZD 1839, in terms of failure-free survival, in patients with malignant mesothelioma. II. Determine the response rate in patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine the overall survival of patients treated with this drug. V. Determine whether overexpression of epidermal growth factor receptor and expression of cyclo-oxygenase-2 can predict the effectiveness of this drug in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --Patient Characteristics-- - Age: Over 18 - Performance status: 0-1 - Life expectancy: Not specified - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - 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 nonmelanomatous 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RamaswamyGovindan, Study Chair, Cancer and Leukemia Group B
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Washington University Siteman Cancer Center
St. Louis, Missouri, 63110
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Additional Information:
Study ID Numbers: CDR0000068938; CLB-30101
Study Start Date: August 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025207
Other Sarcomatous Mesothelioma Studies:
1. Capecitabine in Treating Patients With Malignant Mesothelioma
2. PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma
3. ZD 1839 in Treating Patients With Malignant Mesothelioma
4. Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
5. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
Related Studies:
Other sarcomatous mesothelioma Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
ZD 1839 in Treating Patients With Malignant Mesothelioma
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