T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients
Overview[ - collapse ][ - ]
| Purpose | This is an international, multicenter, randomized study of intravenous T138067 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. |
|---|---|
| Condition | Hepatocellular Carcinoma |
| Intervention | Drug: T138067 intravenous Drug: doxorubicin intravenous |
| Phase | Phase 2/Phase 3 |
| Sponsor | Tularik |
| Responsible Party | Tularik |
| ClinicalTrials.gov Identifier | NCT00057382 |
| First Received | March 31, 2003 |
| Last Updated | June 23, 2005 |
| Last verified | September 2004 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 31, 2003 |
|---|---|
| Last Updated Date | June 23, 2005 |
| Start Date | March 2003 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients |
|---|---|
| Official Title | Not Provided |
| Brief Summary | This is an international, multicenter, randomized study of intravenous T138067 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2/Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Hepatocellular Carcinoma |
| Intervention | Drug: T138067 intravenous Drug: doxorubicin intravenous |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 750 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility 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 ≥ 80,000 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Brazil, China, Poland, Puerto Rico, Russian Federation, Singapore, South Africa, Thailand, Ukraine, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00057382 |
|---|---|
| Other Study ID Numbers | T-067-010 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Tularik |
| Study Sponsor | Tularik |
| Collaborators | Not Provided |
| Investigators | Study Director: Mohammad Hirmand, MD Tularik |
| Verification Date | September 2004 |
Locations[ + expand ][ + ]
| University of Alabama | Birmingham, Alabama, United States, 35294 |
|---|---|
| University of California at San Francisco | San Francisco, California, United States, 94115 |
| University of Miami | Miami, Florida, United States, 33136 |
| VA Medical Center | Miami, Florida, United States, 33125 |
| H. Lee Moffitt Cancer Center | Tampa, Florida, United States, 33612 |
| Loyola University of Chicago | Maywood, Illinois, United States, 60153 |
| University of Pennsylvania | Philadelphia, Pennsylvania, United States, 19104 |
| UT Southwestern Medical Center - Dallas | Dallas, Texas, United States, 75390-9125 |
| Hospital Mater Dei - Departamento de Oncologia | Belo Horizonte, Brazil, 30190131 |
| Hospital Vera Cruz | Belo Horizonte, Brazil, 30190130 |
| Irmandade Santa Casa de Misericórdia de Porto Alegre - Unidade de Apoio à Pesquisa | Porto Alegre, Brazil, 90020090 |
| Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo, Brazil, 5403000 |
| Cancer Center, Sun Yat-Sen Unversity | Guangzhou, Guangdong, China, 510060 |
| Guangzhou Nanfang Hospital | Guangzhou, Guangdong, China, 510515 |
| Queen Mary Hospital | Hong Kong, Hong Kong, China |
| Nanjing Ba Yi Hospital of PLA | Nanjing, Jiangsu, China, 210002 |
| 1st Affiliated Hospital of Xi An Jiao Tong University | Xi AN, Shanxi, China, 710061 |
| Taipei Veteran General Hospital | Taipei, Taiwan, China |
| Chang Gung Memorial Hospital | Tao-Yuan, Taiwan, China |
| Cancer Hospital of Chinese Academy of Medical Science (CAMS) | Beijing, China, 100021 |
| Gereral Hospital of PLA | Beijing, China, 100853 |
| Beijing Cancer Hospital of Peking University | Beijing, China, 100036 |
| Chongqing Southwest Hospital | Chongqing, China, 400038 |
| Prince Wales Hosptial | Hong Kong, China |
| The Affiliated Hospital of Medical College Qingdao University | Qingdao, China, 266003 |
| Shanghai Changzheng Hospital | Shanghai, China, 200070 |
| Liver Cancer Institute, Zhongshan Hospital, Fudan University | Shanghai, China, 200032 |
| Katedra i Klinika Onkologii i Radioterapi Akademii Medycznej | GdaDsk, Poland, 80-211 |
| Oddział Chemioterapii | Olsztyn, Poland, 10-228 |
| Klinika Katedry Onkologii AM | Poznan, Poland, 61-878 |
| San Juan Medical Center | San Juan, Puerto Rico, 00927 |
| Arkhangelsk Redional Oncology Center, Department of Chemotherapy | Arkhangelsk, Russian Federation, 143045 |
| Russian Federation | Barnaul, Russian Federation, 656049 |
| Cheliabinsk Regional Oncology Center | Chelyabinsk, Russian Federation, 545087 |
| Irkutsk Regional Oncology Center | Irkutsk, Russian Federation, 664035 |
| Kazan State Medical University | Kazan, Russian Federation, 420012 |
| Kazan Republican Oncology Clinical Center | Kazan, Russian Federation, 420029 |
| Krasnodar City Oncology Center | Krasnodar, Russian Federation, 350040 |
| Krasnoyarsk Regional Oncology Center | Krasnoyarsk, Russian Federation, 660133 |
| Lipetsk | Lipetsk, Russian Federation, 398005 |
| Central Clinical Hospital of the Ministry of Transport | Moscow, Russian Federation, 129128 |
| Blokhin Cancer Research Center | Moscow, Russian Federation, 115478 |
| Central Clinical Hospital of the President of the Russian Federation | Moscow, Russian Federation, 121356 |
| Novosibirks Municipal Clinical Hospital #1 | Novosibirsk, Russian Federation, 630047 |
| Russian Academy of Medical Sciences | Obninsk, Russian Federation, 249020 |
| Omsk Regional Oncology Center | Omsk 13, Russian Federation |
| Orenburg Regional Oncology Center | Orenburg, Russian Federation, 460021 |
| Moscow Oncology Hospital #62 | P/O Stepanovskoye, Russian Federation, 143423 |
| Rostov Research Oncology Institute | Rostov-on-Don, Russian Federation, 344713 |
| St. Petersburg Mechnikov State Medical Academy | St Petersburg, Russian Federation, 195065 |
| Medical Academy of Postgraduate Education, St. Petersburg | St Petersburg, Russian Federation, 193015 |
| St. Petersburg Oncology Center | St Petersburg, Russian Federation, 197022 |
| Central Research Institute of Radiology of the Ministry of Health of Russian Federation | St Petersburg, Russian Federation, 189646 |
| Stavropol Regional Oncology Center | Stavropol, Russian Federation, 355018 |
| Tomsk Regional Research Institute of Oncology | Tomsk, Russian Federation, 634028 |
| Bashkiria Republican Oncology Center | Ufa, Russian Federation, 450054 |
| Voronezh Regional Clinical Oncology Center | Voronezh, Russian Federation, 394000 |
| Yaroslavl Regional Oncology Center | Yaroslavl, Russian Federation, 150054 |
| Zhitomir Regional Hospital | Zhitomir, Russian Federation, 10002 |
| National University Hospital | Singapore, Singapore, 119074 |
| Eastern Cape Oncology Centre | Port Elizabeth, South Africa |
| Khon Kaen University | Khon Kaen, Thailand, 40002 |
| Chiangmai University | Muang Chiangmai, Thailand, 50200 |
| Dnepropetrovsk State Medical Academy | Dnepropetrovsk, Ukraine, 49102 |
| Donetsk Regional Antitumor Center | Donetsk, Ukraine, 83092 |
| Kiev Central Military Clinical Hospital | Kiev, Ukraine, 01133 |
| Kiev Oncology Institute of Ukrainian Academy of Medical Science | Kiev, Ukraine, 03022 |
| Krivorojsky City Oncology Center | Krivoy Rog, Ukraine, 50048 |
| Lvov State Medical University | Lvov, Ukraine, 79031 |
| Poltava Regional Clinical Oncological Center | Poltava, Ukraine, 36011 |
| Vinnitsa Regional Clinical Oncological Center | Vinnitsa, Ukraine, 21021 |
| Zaporozhje State Medical Institute of Postgraduate Education | Zaporozhye, Ukraine, 69104 |
| Addenbrookes Hospital | Cambridge, United Kingdom, CB2 2QQ |
| Royal Free Hospital | London, United Kingdom, NW3 2QG |
| Hammersmith Hospital | London, United Kingdom, W12 OH5 |
| Christie Hospital | Manchester, United Kingdom, M20 4BX |