Spots Global Cancer Trial Database for Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
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Trial Identification
Brief Title: Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
Official Title: Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
Study ID: NCT01085630
Conditions
Study Description
Brief Summary: RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.
Detailed Description: OBJECTIVES: Primary * To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin. Secondary * To determine the overall survival of patients treated with this regimen versus observation. * To evaluate the frequency of responses in patients treated with this regimen. * To assess the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium), histologic subtype (epithelioid vs other) and number of courses received (\< 6 vs 6). * Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo observation until disease progression. After completion of study therapy, patients are followed up every 6 months for 3 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus, New Britain, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center, Boise, Idaho, United States
Illinois CancerCare - Bloomington, Bloomington, Illinois, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare - Canton, Canton, Illinois, United States
Illinois CancerCare - Carthage, Carthage, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Illinois CancerCare - Eureka, Eureka, Illinois, United States
Galesburg Clinic, PC, Galesburg, Illinois, United States
Illinois CancerCare - Havana, Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic, Kewanee, Illinois, United States
La Grange Memorial Hospital, La Grange, Illinois, United States
Illinois CancerCare - Macomb, Macomb, Illinois, United States
Illinois CancerCare - Monmouth, Monmouth, Illinois, United States
OSF Holy Family Medical Center, Monmouth, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Illinois CancerCare - Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Illinois CancerCare - Pekin, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare - Peru, Peru, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Illinois CancerCare - Princeton, Princeton, Illinois, United States
Illinois CancerCare - Spring Valley, Spring Valley, Illinois, United States
Elkhart Clinic, LLC, Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte, Westville, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal, Liberal, Kansas, United States
Cancer Center of Kansas, PA - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States
Associates in Womens Health, PA - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States
Ochsner Health Center - Bluebonnet, Baton Rouge, Louisiana, United States
Ochsner Health Center - Covington, Covington, Louisiana, United States
New Orleans Cancer Institute at Memorial Medical Center, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Regional Medical Center, Grand Blanc, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
St. Joseph's Medical Center, Brainerd, Minnesota, United States
Essentia Health - Duluth Clinic, Duluth, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller - Dwan Medical Center, Duluth, Minnesota, United States
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
Iredell Memorial Hospital, Statesville, North Carolina, United States
Medcenter One Hospital Cancer Care Center, Bismarck, North Dakota, United States
Mid Dakota Clinic, PC, Bismarck, North Dakota, United States
St. Alexius Medical Center Cancer Center, Bismarck, North Dakota, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Barberton Citizens Hospital, Barberton, Ohio, United States
Cleveland Clinic Beachwood Family Health and Surgery Center, Beachwood, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Cleveland Clinic Cancer Center, Independence, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital, Mayfield Heights, Ohio, United States
Parma Community General Hospital, Parma, Ohio, United States
North Coast Cancer Care, Incorporated, Sandusky, Ohio, United States
Cleveland Clinic Foundation - Strongsville, Strongsville, Ohio, United States
Cleveland Clinic - Wooster, Wooster, Ohio, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Providence Newberg Medical Center, Newberg, Oregon, United States
Willamette Falls Hospital, Oregon City, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States
Geisinger Hazleton Cancer Center, Hazleton, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States
Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
Roper St. Francis Cancer Center at Roper Hospital, Charleston, South Carolina, United States
Danville Regional Medical Center, Danville, Virginia, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Northwest Cancer Specialists at Vancouver Cancer Center, Vancouver, Washington, United States
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States
Contact Details
Name: Arkadiusz Dudek, MD
Affiliation: Masonic Cancer Center, University of Minnesota
Role: STUDY_CHAIR
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