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Sponsored by: |
Lahey Clinic |
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Information provided by: | Lahey Clinic |
ClinicalTrials.gov Identifier: | NCT00808145 |
This study will look at the safety and efficacy of treating advanced hepatocellular carcinoma in patients who have not yet received systemic chemotherapy. Previous local treatment of hepatic lesions is permitted The treatment will use a combination of three FDA approved chemotherapy drugs, Gemcitabine, Cisplatin and Sorafenib. Sorafenib is FDA approved for the treatment of hepatocellular cancer, gemcitabine and cisplatin are not approved for the treatment of hepatocellular cancer.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Drug: Gemcitabine / Cisplatin / Sorafenib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Sorafenib With Gemcitabine/Cisplatin in Advanced Hepatocellular Carcinoma |
Estimated Enrollment: | 30 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Gemcitabine/Cisiplatin/Sorafenib: Experimental
All eligible patients will receive intravenous gemcitabine/cisplatin + daily oral sorafenib until disease progression occurs
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Drug: Gemcitabine / Cisplatin / Sorafenib
All patients will receive gemcitabine 1000mg/m2 cisplatin 30mg/m2 sorafenib 400mg orally twice daily
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This study will look at the effectiveness and safety of combining gemcitabine, cisplatin and sorafenib for the treatment of advanced hepatocellular carcinoma in patients with advanced disease who are chemo naive. Sorafenib has shown an increase in median survival but only tumor shrinkage by RECIST criteria. Since much of the morbidity and mortality of this disease occurs due to continued tumor growth in an already compromised liver, decreasing the size of the tumors might have significant impact on survival. The addition of traditional cytoxic agents might cause measureable tumor response and add to the survival benefit already seen with sorafenib. Gemcitabine and cisplatin are agents commonly used for systemic treatment of this disease and have demonstrated some effectiveness in disease control rate and median time to progression. Gemcitabine/Cisplatin have been used safely in combination with sorafenib in patients with lung cancer.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, liver and renal function as assessed by the following:
Exclusion Criteria:
Contact: Lindsey Watt, BS | 781-744-2766 | Lindsey.B.Watt@Lahey.org |
Contact: Jo Underhill, BSN | 781-744-8400 | Jo.A.Underhill@Lahey.org |
United States, Massachusetts | |
Lahey Clinic | |
Burlington, Massachusetts, United States, 01805 |
Principal Investigator: | Keith E. Stuart, M.D. | Lahey Clinic |
Responsible Party: | Lahey Clinic ( Keith Ellis Stuart, M.D. ) |
Study ID Numbers: | 2008-108 |
Study First Received: | December 11, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00808145 |
Health Authority: | United States: Institutional Review Board |
treatment of advanced liver cancer |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Carcinoma Liver Neoplasms Digestive System Diseases |
Cisplatin 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 Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |