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T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients Clinical research trials and T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients. T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients clinical trial. Participants typically obtain the most effective healthcare available for their T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients  T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients
T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients
For Condition: Hepatocellular Carcinoma
Status: Recruiting
Sponsor(s): Tularik ,
Synopsis: This is an international, multicenter, randomized study of intravenous T138067-sodium versus intravenous doxorubicin in hepatocellular carcinoma (liver cancer). Patients can not have been treated before with chemotherapy and surgery is not recommended for their cancer. A total of 750 subjects will be enrolled in this study.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Key inclusion criteria include: - pathologic diagnosis of unresectable HCC - chemotherapy-naïve for HCC - Child-Pugh Class A or B liver disease - measurable disease (i.e., at least one lesion that is at least 20 mm in one dimension) on computerized tomography (CT) scan or magnetic resonance imaging (MRI) or at least one lesion that is at least 10 mm on spiral CT scan - Karnofsky Performance Status of 70% - life expectancy of 12 weeks - adequate hematologic function (i.e., absolute neutrophil count [ANC] of 1500 cells/mm3, platelet count of 100,000 cells/mm3, hemoglobin of 8.5 g/dL) - total bilirubin of 1.5 upper limit of normal (ULN) - aspartate transaminase (AST) and alanine transaminase (ALT) 5 ULN - serum creatinine of 2 x ULN Key exclusion criteria include: - severe, concurrent disease that would make the subject inappropriate for enrollment - Subjects who have received prior intravenous or intra-arterial chemotherapy, chemoembolization, intratumoral ethanol injection, cryosurgery, radiofrequency ablation, or embolization for their HCC. (note: prior surgical resection, immunotherapy, hormonal therapy, radiotherapy, and/or orthotopic liver transplantation are allowed) - history of other cancer within the past 5 years other than adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix - New York Heart Association (NYHA) class III or IV heart disease or a left ventricular ejection fraction of <50% or acute anginal symptoms - females who are pregnant or breast-feeding - received any investigational agent within 4 weeks of enrollment - history of central nervous system metastases or carcinomatous meningitis - clinically apparent ascites - major surgery within 4 weeks of study enrollment
Total Enrollment: 750
Location and Contact Information:
Overall Study Official:
MohammadHirmand, Study Director, Tularik
Cancer Hospital of Chinese Academy of Medical Science (CAMS) *Recruiting*
Beijing, , 100021
China
Recruiting Yan Wang 861067781331ext 8120
Dnepropetrovsk State Medical Academy *Recruiting*
Dnepropetrovsk, , 49102
Ukraine
Recruiting Vera Kislitsina (0562)580399
Kiev Central Military Clinical Hospital *Recruiting*
Kiev, , 01133
Ukraine
Recruiting Rostislav Gibalo +380 44 261 95 89
Gereral Hospital of PLA *Recruiting*
Beijing, , 100853
China
Recruiting Hong Zhao 861066937098
Krivorojsky City Oncology Center *Recruiting*
Krivoy Rog, , 50048
Ukraine
Recruiting Anna Komissarenko 38 (0564) 721523
Medical Academy of Postgraduate Education, St. Petersburg *Recruiting*
St Petersburg, , 193015
Russian Federation
Recruiting Viktor Kaschenko 7 812 583 1609
Cancer Center, Sun Yat-Sen Unversity *Recruiting*
Guangzhou, Guangdong Province, 510060
China
Recruiting Xiangming Lao 862087343115
Nanjing Ba Yi Hospital of PLA *Recruiting*
Nanjing, Jiangsu Province, 210002
China
Recruiting Liuqing Yang 862586648090
Oddział Chemioterapii *Recruiting*
Olsztyn, , 10-228
Poland
Recruiting Andrzej Kazarnowicz 48895358847
Tomsk Regional Research Institute of Oncology *Recruiting*
Tomsk, , 634028
Russian Federation
Recruiting Marina Matyash 7 3822 41 80 85
Kazan Republican Oncology Clinical Center *Recruiting*
Kazan, , 420029
Russian Federation
Recruiting Guzel Mukhametova 7 8432 19 27 20
University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Kristine Mykulowycz 215-614-0910
Loyola University of Chicago *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Cathy Kalnicky 708-216-2027
Lipetsk *Recruiting*
Lipetsk, , 398005
Russian Federation
Recruiting Elena Kozlovskaya 7 0742 432 460
Blokhin Cancer Research Center *Recruiting*
Moscow, , 115478
Russian Federation
Recruiting Elena Bogush 7 095 324 1740
Lvov State Medical University *Recruiting*
Lvov, , 79031
Ukraine
Recruiting Tatyana Iurchenko 38 (0322) 230972
Omsk Regional Oncology Center *Recruiting*
Omsk 13, ,
Russian Federation
Recruiting Rinat Galiulin 7 3812 292 845
Irmandade Santa Casa de Misericórdia de Porto Alegre - Unidade de Apoio à Pesquisa *Recruiting*
Porto Alegre, , 90020090
Brazil
Recruiting Carla Pires 5191065341
Moscow Oncology Hospital #62 *Recruiting*
P/O Stepanovskoye, , 143423
Russian Federation
Recruiting Liliya Kochenkova 7 095 561 2074
Arkhangelsk Redional Oncology Center, Department of Chemotherapy *Recruiting*
Arkhangelsk, , 143045
Russian Federation
Recruiting Galina Kononova 7 8182 27 59 13
UT Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9125
United States
Recruiting Susan Hensley 214-648-7031
St. Petersburg Mechnikov State Medical Academy *Recruiting*
St Petersburg, , 195065
Russian Federation
Recruiting Elena Drogomiretskaya 7 812 543 94 20
Christie Hospital *Recruiting*
Manchester, , M20 4BX
United Kingdom
Recruiting Michelle Rowe 0161 446 8296
Stavropol Regional Oncology Center *Recruiting*
Stavropol, , 355018
Russian Federation
Recruiting Natalia Levchenko 7 8652 38 36 76
Beijing Cancer Hospital of Peking University *Recruiting*
Beijing, , 100036
China
Recruiting Baocai Xing 861088121122
Hospital Mater Dei - Departamento de Oncologia *Recruiting*
Belo Horizonte, , 30190131
Brazil
Recruiting Fernanda Jorge 3133399022
Yaroslavl Regional Oncology Center *Recruiting*
Yaroslavl, , 150054
Russian Federation
Recruiting Olga Dylinova 7 0852 744 210
Royal Free Hospital *Recruiting*
London, , NW3 2QG
United Kingdom
Recruiting Elizabeth Evans 0207 794 0500
Kazan State Medical University *Recruiting*
Kazan, , 420012
Russian Federation
Recruiting Elvira Gizatullina 7 8432 36 09 12
Vinnitsa Regional Clinical Oncological Center *Recruiting*
Vinnitsa, , 21021
Ukraine
Recruiting Dmitry Bolyukh 38 (0432) 446875
University of Alabama *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting Jennifer Thornton 205-975-6347
VA Medical Center *Recruiting*
Miami, Florida, 33125
United States
Recruiting Debra Gonzalez 305-378-4006
Chongqing Southwest Hospital *Recruiting*
Chongqing, , 400038
China
Recruiting Haihui Huang 862365459990
Hospital Vera Cruz *Recruiting*
Belo Horizonte, , 30190130
Brazil
Recruiting Fernanda Melo 3199424762
Central Clinical Hospital of the President of the Russian Federation *Recruiting*
Moscow, , 121356
Russian Federation
Recruiting Elena Fedoseeva 7 095 414 0362
Johannesburg Hospital *Recruiting*
Johannesburg, ,
South Africa
Recruiting Elaine Sebastian 0027 11 4884452
Pretoria Academic Hospital *Recruiting*
Pretoria, ,
South Africa
Recruiting Era Klerk 0027 12 3542359
Chiangmai University *Recruiting*
Muang Chiangmai, , 50200
Thailand
Recruiting Sutthirak Moolprakarn 66 1472 7537
University of California at San Francisco *Recruiting*
San Francisco, California, 94115
United States
Recruiting Renee Jeffrey 415-353-7145
Voronezh Regional Clinical Oncology Center *Recruiting*
Voronezh, , 394000
Russian Federation
Recruiting Vadim Popov 7 0732 530106
Blokhin Cancer Research Center *Recruiting*
Moscow, , 115478
Russian Federation
Recruiting Igor Bazin 7 095 324 98 64
Liver Cancer Institute, Zhongshan Hospital, Fudan University *Recruiting*
Shanghai, , 200032
China
Recruiting Zhenggang Ren 862164041990
Hospital das ClÃnicas da Faculdade de Medicina da USP *Recruiting*
São Paulo, , 5403000
Brazil
Recruiting Igor Snitcovsky 1130696721
Eastern Cape Oncology Centre *Recruiting*
Port Elizabeth, ,
South Africa
Recruiting Elvira Smuts 0027 41 3736533
Zhitomir Regional Hospital *Recruiting*
 Zhitomir, , 10002
Russian Federation
Recruiting Victor Borschivsky 380 412 37 0442
Prince Wales Hosptial *Recruiting*
Hong Kong, ,
China
Recruiting Jane Koh 85226321142
University of Miami *Recruiting*
Miami, Florida, 33136
United States
Recruiting Angela Marini 305-243-4971
Taipei Veteran General Hospital *Recruiting*
Taipei, Taiwan,
China
Recruiting Ho-Chung Tseng 88622871212
Bashkiria Republican Oncology Center *Recruiting*
Ufa, , 450054
Russian Federation
Recruiting Oleg Lipatov 7 3472 374 358
Klinika Katedry Onkologii AM *Recruiting*
Poznan, , 61-878
Poland
Recruiting Marzena Chajewska-Ciekańska 48618549038
Poltava Regional Clinical Oncological Center *Recruiting*
Poltava, , 36011
Ukraine
Recruiting Evgeny Zaskochenko 38 (0532) 229560
Zaporozhje State Medical Institute of Postgraduate Education *Recruiting*
Zaporozhye, , 69104
Ukraine
Recruiting Sergey Koliadin +380 612 95 3443
San Juan Medical Center *Recruiting*
San Juan, , 00927
Puerto Rico
Recruiting Patricia Rios 787) 758-7348
Khon Kaen University *Recruiting*
Khon Kaen, , 40002
Thailand
Recruiting Chularat Kongphet 6643363364
H. Lee Moffitt Cancer Center *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Shelley Mayfield 813-632-1805
Central Research Institute of Radiology of the Ministry of Health of Russian Federation *Recruiting*
St Petersburg, , 189646
Russian Federation
Recruiting Vladimir Borovik 7 812 596 8596
Russian Academy of Medical Sciences *Recruiting*
Obninsk, , 249020
Russian Federation
Recruiting Yury Petrov 7 08439 7 25 10
Kiev Oncology Institute of Ukrainian Academy of Medical Science *Recruiting*
Kiev, , 03022
Ukraine
Recruiting Sergey Lyalkin +380 44 257 43 19
Donetsk Regional Antitumor Center *Recruiting*
Donetsk, , 83092
Ukraine
Recruiting Yury Ostapenko 38 (0622) 239800
Guangzhou Nanfang Hospital *Recruiting*
Guangzhou, Guangdong Province, 510515
China
Recruiting Hang Zheng 862087640966
1st Affiliated Hospital of Xi An Jiao Tong University *Recruiting*
Xi AN, Shanxi Province, 710061
China
Recruiting Xinhan Zhao 862985324086
National University Hospital *Recruiting*
Singapore, , 119074
Singapore
Recruiting Jasmine Teo 6567724628
Novosibirks Municipal Clinical Hospital #1 *Recruiting*
Novosibirsk, , 630047
Russian Federation
Recruiting Jakov Talovsky 7 3832 251 653
Hammersmith Hospital *Recruiting*
London, , W12 OH5
United Kingdom
Recruiting Anna Ransley 2083833020
Cheliabinsk Regional Oncology Center *Recruiting*
Chelyabinsk, , 545087
Russian Federation
Recruiting Ekateina Nikolskaya 7 3512 607239
Central Clinical Hospital of the Ministry of Transport *Recruiting*
Moscow, , 129128
Russian Federation
Recruiting Julia Bolshakova 7 095 187 7483
Krasnoyarsk Regional Oncology Center *Recruiting*
Krasnoyarsk, , 660133
Russian Federation
Recruiting Natalya Zima 7 3912 671 715
Krasnodar City Oncology Center *Recruiting*
Krasnodar, , 350040
Russian Federation
Recruiting Olga Oleinikova 7 8612 33 64 98
The Affiliated Hospital of Medical College Qingdao University *Recruiting*
Qingdao, , 266003
China
Recruiting Hua Zhu 865322911347
Katedra i Klinika Onkologii i Radioterapi Akademii Medycznej *Recruiting*
GdaDsk, , 80-211
Poland
Recruiting Agnieszka Pilszka 48583492254
Irkutsk Regional Oncology Center *Recruiting*
Irkutsk, , 664035
Russian Federation
Recruiting Dmitry Ponomarenko 7 3952 242 642
Addenbrookes Hospital *Recruiting*
Cambridge, , CB2 2QQ
United Kingdom
Recruiting Marie Corcoran 01223 216 083
Rostov Research Oncology Institute *Recruiting*
Rostov-on-Don, , 344713
Russian Federation
Recruiting Natalia Abramova 7 8632 538 546
Orenburg Regional Oncology Center *Recruiting*
Orenburg, , 460021
Russian Federation
Recruiting Olga Egorova 7 3532 331 322
Shanghai Changzheng Hospital *Recruiting*
Shanghai, , 200070
China
Recruiting Li Sun 862166540109
Addington Hospital *Recruiting*
Durban, ,
South Africa
Recruiting Linda Ross 0027 31 3272245
Chang Gung Memorial Hospital *Recruiting*
Tao-Yuan, Taiwan,
China
Recruiting C.C. Liu 88633281200
St. Petersburg Oncology Center *Recruiting*
St Petersburg, , 197022
Russian Federation
Recruiting Andrey Pavlysh 7 812 152 1414
Additional Information:
Study ID Numbers: T-067-010;
Study Start Date: March 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057382
Other Hepatocellular Carcinoma Studies:
1. T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients
2. Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads
3. Prevention of Recurrent Hepatitis B after Liver Transplantation
4. Safety and Tolerability of I.V. Infusion of MB07133 in Patients with Unresectable Hepatocellular Carcinoma
5. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies
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T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients
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