Mesothelioma articles - clinical trial : pemetrexed disodium .

Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Mesothelioma Articles
Pemetrexed Disodium and Either Gemcitabine or Carboplatin in Treating Patients With Advanced Malignant Pleural
Mesothelioma
This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) July 2006 Sponsors and Collaborators: Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00101283
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways tostop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combinationchemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective PURPOSE: This randomized phase II trial is studying pemetrexed disodium and gemcitabine to see how well they work compared topemetrexed disodium and carboplatin in treating patients with advanced malignant pleural mesothelioma.
Condition
Intervention
Drug: gemcitabine hydrochloride Drug: pemetrexed disodium Procedure: chemotherapy MedlinePlus related topics: Cancer; Cancer Alternative Therapies; MesotheliomaGenetics Home Reference related topics: Cancer Study Type: InterventionalStudy Design: Treatment Official Title: Phase II Randomized Study of Pemetrexed Disodium Combined With Either Gemcitabine or Carboplatin in PatientsWith Advanced Malignant Mesothelioma of the Pleura Further study details as provided by National Cancer Institute (NCI): Compare the response rates in patients with advanced malignant mesothelioma of the pleura treated with pemetrexed disodium combined with either gemcitabine or carboplatin.
Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Compare the relative toxic effects of these regimens in these patients.
Compare survival time in patients treated with these regimens.
Correlate smoking status with outcome in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1.
Arm II: Patients receive pemetrexed disodium as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Beginning approximately 5-10 days before the start of chemotherapy and continuing until approximately 3 weeks after completion ofchemotherapy, all patients receive oral folic acid once daily and cyanocobalamin (vitamin B12) intramuscularly every 9 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 32-60 patients (16-30 per treatment arm) will be accrued for this study within 12.8-27.0 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Cytologically confirmed advanced mesothelioma of the pleura Unmeasurable pleural rinds allowed provided disease is evaluable by mesothelioma response criteria The following are not considered measurable disease: Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
http://mirg.org/mesothelioma-articles/pdf/clinical-trial-pemetrexed-diso.
Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement) Able to take folic acid and cyanocobalamin (vitamin B12) No weight loss > 10% within the past 6 weeks No other serious systemic disorder that would preclude study participation No other malignancy within the past 3 years except carcinoma of the cervix or breast, other malignancies, or adequately treated basal cell skin cancer Fertile patients must use effective contraception during and for 3 months after study participation No prior intracavitary immunomodulators except for the purpose of pleurodesis Prior radiotherapy to the target lesion allowed provided both of the following criteria are met: The lesion is clearly progressing after prior radiotherapy At least 4 weeks since prior radiotherapy Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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More than 2 weeks since prior pleurodesis More than 4 weeks since prior investigational agents No prior intracavitary cytotoxic drugs except for the purpose of pleurodesis No aspirin or other nonsteroidal anti-inflammatory drugs for 2 days before, during, and for 2 days after each administration ofpemetrexed disodium (5 days before, during, and 2 days after each administration of pemetrexed disodium for piroxicam,naproxen, diflunisal, or nabumetone) Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00101283 Delaware
Beebe Medical Center, Lewes, Delaware, 19958, United States; Recruiting Clinical Trials Office - Beebe Medical Center 302-645-3171 CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227 Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, 32207, United States; Recruiting Clinical Trials Office - Baptist Cancer Institute - Jacksonvil 904-202-7051 Winship Cancer Institute of Emory University, Altanta, Georgia, 30322, United States; Recruiting Illinois
BroMenn Regional Medical Center, Normal, Illinois, 61761, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, 61554, United States; Recruiting Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, 61801, United States; Recruiting Clinical Trials Office - Carle Cancer Center 800-446-5532 CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting Clinical Trials Office - CCOP - Carle Cancer Center 800-446-5532 CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615, United States; Recruiting Community Cancer Center, Normal, Illinois, 61761, United States; Recruiting Community Hospital of Ottawa, Ottawa, Illinois, 61350, United States; Recruiting Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, 62526, United States; Recruiting Eureka Community Hospital, Eureka, Illinois, 61530, United States; Recruiting Galesburg Clinic, Galesburg, Illinois, 61401, United States; Recruiting Galesburg Cottage Hospital, Galesburg, Illinois, 61401, United States; Recruiting Moline, Illinois, 61265, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Graham Hospital, Canton, Illinois, 61520, United States; Recruiting Hopedale Medical Complex, Hopedale, Illinois, 61747, United States; Recruiting Illinois Valley Community Hospital, Peru, Illinois, 61354, United States; Recruiting Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, 60435, United States; Recruiting Kewanee Hospital, Kewanee, Illinois, 61443, United States; Recruiting Mason District Hospital, Havana, Illinois, 62644, United States; Recruiting McDonough District Hospital, Macomb, Illinois, 61455, United States; Recruiting Memorial Hospital, Carthage, Illinois, 62321, United States; Recruiting Methodist Medical Center of Illinois, Peoria, Illinois, 61636, United States; Recruiting Clinical Trials Office - Methodist Medical Center of Illinois 309-243-3000 Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, 61350, United States; Recruiting Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, 61615, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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OSF St. Francis Medical Center, Peoria, Illinois, 61637, United States; Recruiting Perry Memorial Hospital, Princeton, Illinois, 61356, United States; Recruiting Proctor Hospital, Peoria, Illinois, 61614, United States; Recruiting Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, 62781, United States; Recruiting Clinical Trials Office - Regional Cancer Center 217-788-4233 Rush-Copley Cancer Care Center, Aurora, Illinois, 60507, United States; Recruiting St. Joseph Medical Center, Bloomington, Illinois, 61701, United States; Recruiting St. Margaret's Hospital, Spring Valley, Illinois, 61362, United States; Recruiting Trinity Medical Center - East, Moline, Illinois, 61265, United States; Recruiting Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States; Recruiting Clinical Trials Office - Indiana University Cancer Center 317-274-2552 Reid Hospital & Health Care Services, Incorporated, Richmond, Indiana, 47374, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Saint Anthony Memorial Health Centers, Michigan City, Indiana, 46360, United States; Recruiting St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, 46107, United States; Recruiting Veterans Affairs Medical Center - Indianapolis, Indianapolis, Indiana, 46202, United States; Recruiting William N. Wishard Memorial Hospital, Indianapolis, Indiana, 46202, United States; Recruiting Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, 52403, United States; Recruiting Clinical Trials Office - Cedar Rapids Oncology Associates 319-363-2690 Bettendorf, Iowa, 52722, United States; Recruiting McFarland Clinic, P. C., Ames, Iowa, 50010, United States; Recruiting Clinical Trials Office - McFarland Clinic, P. C. 515-239-2621 Mercy Medical Center - Sioux City, Sioux City, Iowa, 51104, United States; Recruiting Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, 52403, United States; Recruiting Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, 51101, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Siouxland Regional Cancer Center, Sioux City, Iowa, 51101, United States; Recruiting Clinical Trials Office - Siouxland Regional Cancer Center 712-252-9349 St. Luke's Hospital, Cedar Rapids, Iowa, 52402, United States; Recruiting St. Luke's Regional Medical Center, Sioux City, Iowa, 51104, United States; Recruiting Maryland
Union Hospital Cancer Center at Union Hospital, Elkton MD, Maryland, 21921, United States; Recruiting Michigan
Borgess Medical Center, Kalamazooaa, Michigan, 49001, United States; Recruiting Bronson Methodist Hospital, Kalamazoo, Michigan, 49007, United States; Recruiting West Michigan Cancer Center, Kalamazoo, Michigan, 49007-3731, United States; Recruiting Clinical Trials Office - West Michigan Cancer Center 269-373-7458 Minnesota
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Fairview Ridges Hospital, Burnsville, Minnesota, 55337, United States; Recruiting Fairview Southdale Hospital, Edina, Minnesota, 55435, United States; Recruiting Clinical Trials Office - Fairview Southdale Hospital 612-625-3650 HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, 55109, United States; Recruiting Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, 55415, United States; Recruiting Clinical Trials Office - Hennepin County Medical Center - Minn 612-873-5911 Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota, 55422-2900, UnitedStates; Recruiting Clinical Trials Office - Hubert H. Humphrey Cancer Center 763-520-1893 Hutchinson Area Health Care, Hutchinson, Minnesota, 55350, United States; Recruiting Meeker County Memorial Hospital, Lichfield, Minnesota, 55355, United States; Recruiting Clinical Trials Office - Meeker County Memorial Hospital 320-693-4520 Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, 55432, United States; Recruiting Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, 55433, United States; Recruiting Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, 55125, United States; Recruiting Minnesota Oncology Hematology, PA at Maplewood Cancer Center, Maplewood, Minnesota, 55109, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Park Nicollet Health Services, St. Louis Park, Minnesota, 55416, United States; Recruiting Regions Hospital Cancer Care Center, St. Paul, Minnesota, 55101, United States; Recruiting Clinical Trials Office - Regions Hospital Cancer Care Center 651-254-1517 Ridgeview Medical Center, Waconia, Minnesota, 55387, United States; Recruiting Saint Francis Cancer Center, Shakopee, Minnesota, 55379, United States; Recruiting St. Joseph's Hospital, St Paul, Minnesota, 55102, United States; Recruiting United Hospital, St. Paul, Minnesota, 55102, United States; Recruiting Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota, 55407, United States; Recruiting Clinical Trials Office - Virginia Piper Cancer Institute at Ab 612-863-5654 Woodwinds Health Campus, Woodbury, Minnesota, 55125, United States; Recruiting New Jersey
Booker Cancer Center at Riverview Medical Center, Red Bank, New Jersey, 07701, United States; Recruiting Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, 08043, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Clinical Trials Office - Cancer Institute of New Jersey 856-325-6757 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting Clinical Trials Office - Cancer Institute of New Jersey at UMD 732-235-8675 Fox Chase Virtua Health Cancer Program at Virtua West Jersey, Voorhees, New Jersey, 08043, United States; Recruiting Fox Chase Virtua Health Cancer Program - Marlton, Marlton, New Jersey, 08053, United States; Recruiting Clinical Trials Office - Fox Chase Virtua Health Cancer Progra 888-847-8823 Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, 07018-1095, United States; Recruiting Basil S. Kasimis, MD, DSc 973-676-1000 ext 1406 Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting Clinical Trials Office - Albert Einstein Cancer Center 718-430-2302 Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York, 10466, United States; Recruiting North Dakota
Bismarck Cancer Center, Bismarck, North Dakota, 58501, United States; Recruiting Cancer Care Center at Medcenter One Hospital, Bismarck, North Dakota, 58501, United States; Recruiting Mid Dakota Clinic, P. C., Bismarck, North Dakota, 58501, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Clinical Trials Office - Mid Dakota Clinic, P. C. 701-530-6950 St. Alexius Medical Center, Bismarck, North Dakota, 58502, United States; Recruiting Clinical Trials Office - St. Alexius Medical Center 701-530-6950 Akron City Hospital, Akron, Ohio, 44309-2090, United States; Recruiting Clinical Trials Office - Akron City Hospital 330-375-6101 Aultman Hospital Cancer Center at Aultman Health Foundation, Canton, Ohio, 44710-1799, United States; Recruiting Clinical Trials Office - Aultman Hospital Cancer Center 330-363-4857 CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting Charles F. Kettering Memorial Hospital, Kettering, Ohio, 45429, United States; Recruiting Clinical Trials Office - Charles F. Kettering Memorial Hospita 937-298-3399 ext. 55506 Christ Hospital Cancer Center, Cincinnati, Ohio, 45219, United States; Recruiting Good Samaritan Hospital, Dayton, Ohio, 45406, United States; Recruiting Grandview Hospital, Dayton, Ohio, 45405, United States; Recruiting Middletown Regional Hospital, Middletown, Ohio, 45044, United States; Recruiting Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, 45385, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Samaritan North Cancer Care Center, Dayton, Ohio, 45415, United States; Recruiting St. Rita's Medical Center, Lima, Ohio, 45801, United States; Recruiting Clinical Trials Office - St. Rita's Medical Center 419-226-9617 UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, 45373-1300, United States; Recruiting Clinical Trials Office - UVMC Cancer Care Center 937-440-4842 Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428, United States; Recruiting/ Pennsylvania
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, 19141, United States; Recruiting Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, 19111-2497, United States; Recruiting Clinical Trials Office - Fox Chase Cancer Center 215-728-4790 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, 18711, United States; Recruiting Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce 570-271-5251 Geisinger Medical Center, Danville, Pennsylvania, 17822-0001, United States; Recruiting Clinical Trials Office - Geisinger Medical Center 570-271-5251 Geisinger Medical Group - Scenery Park, State College, Pennsylvania, 16801, United States; Recruiting Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Lewistown Hospital, Lewistown, Pennsylvania, 17044, United States; Recruiting Mount Nittany Medical Center, State College, Pennsylvania, 16803, United States; Recruiting Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, UnitedStates; Recruiting Clinical Trials Office - Penn State Cancer Institute 717-531-3779 South Dakota
Avera Cancer Institute, Sioux Falls, South Dakota, 57105, United States; Recruiting Medical X-Ray Center, PC, Sioux Falls, South Dakota, 57105, United States; Recruiting Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, 57117-5039, UnitedStates; Recruiting Clinical Trials Office - Sioux Valley Hospital and University 605-328-1367 Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, 54601, UnitedStates; Recruiting Clinical Trials Office - Gundersen Lutheran Cancer Center 608-775-2385 Nasser H. Hanna, MD, Study Chair, Indiana University School of Medicine Corey J. Langer, MD, Fox Chase Cancer Center - Philadelphia Scott Okuno, MD, Study Chair, Mayo Clinic More Information
Mesothelioma Articles - Clinical Trial : Pemetrexed Disodium and Eithe.
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Clinical trial summary from the National Cancer Institute's PDQ® database Study ID Numbers: CDR0000401795; ECOG-E1B03; NCCTG-E1B03Last Updated: July 13, 2006Record first received: January 7, 2005ClinicalTrials.gov Identifier: NCT00101283Health Authority: United States: Federal Government ClinicalTrials.gov processed this record on 2006-08-10

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