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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00471965 |
Primary:
Secondary:
Condition | Intervention | Phase |
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Carcinoma, Hepatocellular |
Drug: Oxaliplatin + 5-Fluorouracil/Leucovorin Drug: Doxorubicin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Oxaliplatin(Eloxatin®) + 5-FU/LV (FOLFOX4) Compared With Single Agent Doxorubicin (Adriamycin®) as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients Ineligible for Curative Resection or Local Treatment |
Estimated Enrollment: | 440 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Oxaliplatin + 5-Fluorouracil/Leucovorin
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Drug: Oxaliplatin + 5-Fluorouracil/Leucovorin
Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion. Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion. Repeated every 2 weeks |
B: Active Comparator
Doxorubicin
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Drug: Doxorubicin
Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate organ and marrow function:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact: Public Registry GMA | PublicRegistryGMA@sanofi-aventis.com |
China | |
Sanofi-Aventis | Recruiting |
Shanghai, China | |
Korea, Republic of | |
Sanofi-Aventis | Active, not recruiting |
Seoul, Korea, Republic of | |
Taiwan | |
Sanofi-Aventis | Recruiting |
Taipei, Taiwan | |
Thailand | |
Sanofi-Aventis | Recruiting |
Bangkok, Thailand |
Study Director: | Benedict Blayney | Sanofi-Aventis |
Responsible Party: | Sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | OXALI_L_00858 |
Study First Received: | May 9, 2007 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00471965 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Antimetabolites Liver Diseases Vitamin B Complex Digestive System Neoplasms Immunologic Factors Carcinoma, Hepatocellular Leucovorin Trace Elements Immunosuppressive Agents Doxorubicin Carcinoma |
Liver Neoplasms Anti-Bacterial Agents Oxaliplatin Digestive System Diseases Vitamins Fluorouracil Gastrointestinal Neoplasms Micronutrients Adenocarcinoma Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Liver Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Carcinoma, Hepatocellular Antineoplastic Agents Physiological Effects of Drugs Leucovorin Antibiotics, Antineoplastic Liver Neoplasms Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Vitamin B Complex Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Immunosuppressive Agents Doxorubicin Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Fluorouracil Adenocarcinoma Neoplasms, Glandular and Epithelial |