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Capecitabine in Treating Patients With Malignant Mesothelioma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Capecitabine in Treating Patients With Malignant Mesothelioma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Capecitabine in Treating Patients With Malignant Mesothelioma Clinical research trials and Capecitabine in Treating Patients With Malignant Mesothelioma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Capecitabine in Treating Patients With Malignant Mesothelioma. Capecitabine in Treating Patients With Malignant Mesothelioma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Capecitabine in Treating Patients With Malignant Mesothelioma clinical trial. Test subjects typically receive the most effective healthcare possible for their Capecitabine in Treating Patients With Malignant Mesothelioma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Capecitabine in Treating Patients With Malignant Mesothelioma  Capecitabine in Treating Patients With Malignant Mesothelioma
Capecitabine in Treating Patients With Malignant Mesothelioma
For Condition: recurrent malignant mesothelioma,advanced malignant mesothelioma,epithelial mesothelioma,localized malignant mesothelioma,sarcomatous mesothelioma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have malignant mesothelioma.
Details: OBJECTIVES: I. Determine the response rate, overall survival, and failure free survival of patients with malignant mesothelioma treated with capecitabine. II. Determine the toxicity of this regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 3 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 7-9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven malignant mesothelioma not amenable to potentially curative radiotherapy or surgery; Epithelial, sarcomatoid, or mixed subtype; Any site of origin allowed including, but not limited to, the following: Pleura; Peritoneum; Pericardium; Tunica vaginalis - Measurable disease; At least one lesion accurately measured in at least one dimension; Lesion at least 20 mm at largest diameter with conventional techniques or at least 10 mm with spiral CT scan - The following are not considered measurable disease: Bone lesions; Leptomeningeal disease; Ascites; Pleural/pericardial effusion; Abdominal masses not confirmed and followed by imaging techniques; Cystic lesions; Tumor lesions located in a previously irradiated area --Prior/Concurrent Therapy-- - Biologic therapy: Concurrent epoetin alfa allowed - Chemotherapy: No prior systemic cytotoxic chemotherapy for malignant mesothelioma; Prior intrapleural cytotoxic or sclerosing agents (including bleomycin) allowed; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy except the following: Steroids administered for adrenal failure; Hormonal therapy administered for nonmalignant conditions (e.g., insulin for diabetes); Intermittent use of dexamethasone as an antiemetic - Radiotherapy: At least 4 weeks since prior radiotherapy; Prior irradiation of symptomatic lesion allowed if there is other measurable disease outside the radiation port; No concurrent radiotherapy - Surgery: At least 2 weeks since prior major surgery - Other: No concurrent leucovorin calcium or folinic acid --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0 or 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 - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No active second malignancy except nonmelanomatous skin; Not considered an active second malignancy if: Therapy has been completed; Less than 30% risk of relapse according to the physician; No malabsorption syndrome
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GregoryOtterson, Study Chair, Cancer and Leukemia Group B
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Additional Information:
Study ID Numbers: CDR0000067422; CLB-39807
Study Start Date: November 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004183
Other Recurrent Malignant Mesothelioma Studies:
1. Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma
2. Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
3. Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
4. Capecitabine in Treating Patients With Malignant Mesothelioma
5. Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
Related Studies:
Other recurrent malignant mesothelioma Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Capecitabine in Treating Patients With Malignant Mesothelioma
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