Spots Global Cancer Trial Database for Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer
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Trial Identification
Brief Title: Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer
Official Title: A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine
Study ID: NCT00099294
Conditions
Interventions
Study Description
Brief Summary: The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.
Detailed Description: TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells. Study Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care. Comparison: Glufosfamide versus best supportive care.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Augusta Oncology Associates, Los Angeles, California, United States
Kenmar Research Institute, Los Angeles, California, United States
Mile High Oncology, Denver, Colorado, United States
Northwestern Connecticut Oncology - Hematology Associates, Torrington, Connecticut, United States
Palm Beach Institute of Hematology and Oncology, Boynton Beach, Florida, United States
Hematology/Oncology of the North Shore, Skokie, Illinois, United States
Fort Wayne Medical Oncology/Hem, Fort Wayne, Indiana, United States
Norton Healthcare Center, Louisville, Kentucky, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Hattiesburg Clinic Oncology, Hattiesburg, Mississippi, United States
Columbia Comprehensive Cancer Care Clinic, Columbia, Missouri, United States
Bond Clinic, Rolla, Missouri, United States
Deaconess Billings Clinic, Billings, Montana, United States
Office of Clinical Trials, Paramus, New Jersey, United States
New Mexico Oncology Hematology Consultants, Albuquerque, New Mexico, United States
Hanover Medical Specialists, Wilmington, North Carolina, United States
Vita Hematology Oncology PC, Bethlehem, Pennsylvania, United States
The Family Cancer Center , PLLC, Collierville, Tennessee, United States
Center for Oncology Research and Treatment, Dallas, Texas, United States
JPS Center for Cancer Care, Fort Worth, Texas, United States
Northern Utah Associates, Ogden, Utah, United States
Cancer Outreach Association, Abingdon, Virginia, United States
Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Hospital Interzonal General de Agudos, Buenos Aires, , Argentina
Hospital Posadas, Buenos Aires, , Argentina
Policlinica Privada Instituto de Medicina Nuclear, Buenos Aires, , Argentina
Hospital Udaondo, Buenos Aires, , Argentina
Hospital Alvarez, Buenos Aires, , Argentina
Hospital Churruca - Visca, Buenos Aires, , Argentina
Instituto Medico Alexander Fleming, Buenos Aires, , Argentina
Instituto CAICI, Santa Fe, , Argentina
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, , Brazil
Fundação Pio XII - Hospital de Câncer de Barretos, Barretos, , Brazil
Hospital Vera Cruz - Clinica de Oncologia, Belo Horizonte, , Brazil
Hospital Luxemburgo, Belo Horizonte, , Brazil
Hospital de Clínicas da UFPR, Curitiba, , Brazil
Associacao de Combate ao Cancer em Goias, Hospital Araujo Jorge, Setor de Oncologia Clinica, Goiania, , Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, , Brazil
Instituto Nacional do Cancer - INCA, Rio de Janeiro, , Brazil
Clinica de Oncologia Medica S/C Ltda, Sao Paulo, , Brazil
Hospital do Cancer - AC Camargo, Sao Paulo, , Brazil
Grupo Paulista Oncologia Integrada, São Paulo, , Brazil
Department of Chemotherapy Dr. Georgi Stranski General Hospital of Pleven University, Pleven, , Bulgaria
First Internal Department Plovdiv Regional Oncology Center with In-patient Department, Plovdiv, , Bulgaria
Department of Chemotherapy Sofia Regional Oncology Center, Sofia, , Bulgaria
Chemotherapy Clinic Queen Joanna General Hospital, Sofia, , Bulgaria
Haematology and Oncology Clinic Military Medical Academy, Sofia, , Bulgaria
Chemotherapy Clinic Specialized Oncology Hospital, Sofia, , Bulgaria
Department of Chemotherapy Veliko Tarnovo Regional Oncology Center, Tarnovo, , Bulgaria
Department of Medicinal Oncotherapy and Palliative Care Dr. Marko Markov Regional Oncology Center, Varna, , Bulgaria
Fakultni nemocnice Brno Oddeleni Klinicke Onkologie, Brno, , Czech Republic
Masarykuv onkologicky Ustav, Brno, , Czech Republic
Krajska nemocnice Pardubice,oddeleni Radiacni Onkologie, Kyjevska, , Czech Republic
Onkologicka Klinika, Fakultni nemocnice Olomouc, Olomouc, , Czech Republic
Onkologicke Oddeleni, Batova krajska nemocnice Zlin, Zlin, , Czech Republic
National Institute of Oncology, Budapest, , Hungary
Szent Imre Korhaz Onkologia, Budapest, , Hungary
Szent László Kórház, Onkológia, Budapest, , Hungary
Vaszary Kolos Korhaz, Esztergom, , Hungary
Petz Aladar County Hospital, Department of Oncology, Gyor, , Hungary
Baranya megyei Korhaz Onkologial osztaly, Rakoczi, , Hungary
Bangalore Institute of Oncology, Bangalore, , India
Curie Centre of Oncology, Bangalore, , India
Radhakrishan Birla Cancer Centre, Jaipur, , India
Jaslok Hospital and Research Centre, Mumbai, , India
Sir Ganga Ram Hospital, New Delhi, , India
Hospital Universitario "Dr. Angel Leano", Zapopan, Jalisco, Mexico
Hospital y Clinica OCA S.A. De C.V., Monterrey, NL, Mexico
Hospital Central "Dr. Ignacio Morones Prieto" Departamento de Radioterapia., San Luis Potosi, SLP, Mexico
Hospital regional ISSSTE "Merida", Merida, Yucatan, Mexico
Centro Estatal de Cancerologia, Chihuahua, , Mexico
Hospital Clinica del Parque, Chihuahua, , Mexico
Centro Medico ISSEMYM, Metepec, , Mexico
Hospital general "5 de Diciembre" ISSSTE, Mexicali, , Mexico
Hospital Regional de Especialidades No. 30 IMSS, Mexicali, , Mexico
Hospital de Oncologia Centro Medico, Mexico, DF, , Mexico
Instituto Nacional de Ciencias Medicas u Nutricion "Salvador Zubiran", Mexico, DF, , Mexico
Fundeni Clinical Institute, Bucharest, , Romania
Trestioreanu Institute of Oncology, Bucharest, , Romania
"I. Chiricuta" Institute of Oncology, Cluj-Napoca, , Romania
Craiova Emergency Clinical County Hospital, Craiova, , Romania
Timisoara City Hospital, Timisoara, , Romania
Institute of Medical Radiology, Russian Academy of Medical Science, Obninsk, Kaluzhskaya Region, Russian Federation
Cheliabinsk Regional Oncology Center, Cheliabinsk, , Russian Federation
Irkutsk Regional Oncology Center, Irkutsk, , Russian Federation
Clinical Oncology Center, Kazan, , Russian Federation
Krasnodar City Oncology Center, Krasnodar, , Russian Federation
Blokhin Cancer Research Center, Dept of Clinical Pharmacology and Chemotherapy, Moscow, , Russian Federation
Central Clinical Hospital of the presidentof the Russian Federation, Moscow, , Russian Federation
Hertzen Research Institute of Oncology, Moscow, , Russian Federation
Central Clinical Hospital of the Ministru of Transport n.a. Semashko, Moscow, , Russian Federation
Orenburg, Regional Oncology Center, Orenburg, , Russian Federation
Samara Oncology Center, Samara, , Russian Federation
St. Petersburg, Central Research Institute of Radiology, St. Petersburg, , Russian Federation
Medical Academy of Postgraduate Education, St. Petersburg, , Russian Federation
St. Petersburg Oncology Center, St. Petersburg, , Russian Federation
Mechnikov State Medical Academy, St.Petersburg, , Russian Federation
Voronezh Regional Clinical Oncology Center, Voronezh, , Russian Federation
Yaroslavl Regional Oncology Center, Yaroslavl, , Russian Federation
Dnepropetrovsk City Clinical Hospital, Dnepropetrovsk, , Ukraine
Donetsk Regional Antitumor Center, Donetsk, , Ukraine
State Communal Healthcare Institution: Kharkov Regional Clinical Oncological Center, Kharkov, , Ukraine
Institute of Oncology under the Academy of Medical Sciences of Ukraine, Kiev, , Ukraine
Kiev Municipal Clinical Hospital #10, Kiev Center for Biliary, Biliary tracts and Pancreas Surgery, Kiev, , Ukraine
Krivoy Rog City Oncology Center, Krivoy Rog, , Ukraine
Lugansk Regional Clinical Oncological Center, Lugansk, , Ukraine
Nikolaev Regional Oncology Centre, Nikolaev, , Ukraine
Odessa Regional Clinical Hospital, Odessa, , Ukraine
Vinnitsa Regional Clinical Oncology Center, Vinnitsa, , Ukraine
Zaporozhye Medical Academy of Postgraduate Education, Zaporozhye, , Ukraine
Zhitomir Regional Clinical Hospital n.a. O.F. Gerbachevsky, Zhitomir, , Ukraine
Contact Details
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