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Sponsors and Collaborators: |
Mahidol University Bayer Chulalongkorn University Bumrungrad International Hospital |
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Information provided by: | Mahidol University |
ClinicalTrials.gov Identifier: | NCT00703365 |
This study is to evaluate the efficacy and safety of Sorafenib in combination with Gemcitabine in patients with advanced/unresectable HCC.
Condition | Intervention | Phase |
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Carcinoma, Hepatocellular |
Drug: Sorafenib and Gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open Label, Single Arm, Phase II Study to Investigate the Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Patients With Advanced Hepatocellular Carcinoma (HCC) |
Estimated Enrollment: | 45 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Sorafenib and Gemcitabine
Sorafenib 400 mg po bid daily and Gemcitabine IV 1,000 mg/m2 on day 1,8, 15 of a 28-day cycle (up to 6 cycles), then followed by Sorafenib 400 mg po bid daily maintenance until disease progression.
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Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the fifth most common cancer in the world. It is responsible for about 90 percent of the primary malignant liver tumors observed in adult and disproportionately affects men, with about three times as many men developing the disease as women.
Common symptoms in patients affected with HCC include abdominal pain, weight loss, weakness, fullness and anorexia, abdominal swelling, jaundice and vomiting.
Multiple clinical staging systems for hepatic tumors have been used such as the American Joint Committee on Cancer TNM system (stage 0, A, B, C, D) etc. However, the staging systems are still evolving with all attempts to improve the classification and prognosis prediction of HCC, and there is no agreement on the best staging that can be recommended world-wide.
For advanced HCC, sorafenib is likely to become the new standard of care. Combinational therapies with sorafenib have the potential to further improved therapeutic options for patients suffering from advanced HCC. Gemcitabine is a classical chemotherapeutic substance that has modest anti-cancer activity in HCC. However, its anti-cancer activity seems to be improved when combined with other anti-cancer drugs including drugs interfering with the VEGF pathway. Both substances, sorafenib and gemcitabine, have a favorable safety profile with a minimal overlap of side effects. Further the mode of actions of sorafenib and gemcitabine are likely to result in synergistic anti-tumor effects.
An open label, single arm, multicenter phase II study designed to determine progression free survival of patients with advanced stage HCC treated with sorafenib in combination with gemcitabine. Patients will receive up to 6 cycles of gemcitabine(IV 1000 mg/m2 on day 1, 8, 15 of a 28-day cycle) in combination with sorafenib (400 mg po bid daily) followed by sorafenib (400 mg po bid daily) maintenance until disease progression.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vichien Srimuninnimit, Assist.Prof. | 662-419-7000 ext 4488 | sivsm@mahidol.ac.th |
Thailand, Bangkok | |
Department of Medicine, Siriraj Hospital | Recruiting |
Bangkoknoi, Bangkok, Thailand, 10700 | |
Contact: Vichien Srimuninnimit, Asst.Prof. 662-419-7000 ext 4488 sivsm@mahidol.ac.th | |
Principal Investigator: Vichien Srimuninnimit, Asst.Prof. | |
Medical Oncology Unit, Chulalongkorn Hospital | Recruiting |
Patumwan, Bangkok, Thailand, 10330 | |
Contact: Virote Sriuranpong, Asst.Prof. 662-256-4533 Virote.S@chula.ac.th | |
Sub-Investigator: Virote Sriuranpong, Asst.Prof. | |
Horizon Regional Cancer Center, Bamrungrad Hospital | Recruiting |
Sukhumvit 3, Bangkok, Thailand, 10110 | |
Contact: Suthida Suwanvecho, M.D. 662-667-2521 | |
Sub-Investigator: Suthida Suwanvecho, M.D. |
Principal Investigator: | Vichien Srimuninnimit, Assist.Prof. | Siriraj Hospital, Bangkok, Thailand |
Responsible Party: | Department of Medicine, Siriraj Hospital ( Asst.Prof.Vichien Srimuninnimit ) |
Study ID Numbers: | 12849 |
Study First Received: | May 20, 2008 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00703365 |
Health Authority: | Thailand: Food and Drug Administration |
Hepatocellular Carcinoma (HCC) |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Carcinoma Liver Neoplasms Digestive System Diseases |
Gastrointestinal Neoplasms Adenocarcinoma Gemcitabine Sorafenib Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |