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Sponsored by: |
ARCAGY/ GINECO GROUP |
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Information provided by: | ARCAGY/ GINECO GROUP |
ClinicalTrials.gov Identifier: | NCT00268840 |
The purpose of this study is to assess the efficacy of combination therapy with gemcitabine and docetaxelin in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma.
Condition | Intervention | Phase |
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Pancreatic Neoplasms Biliary Tract Neoplasms |
Drug: Docetaxel Drug: Gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | National Trial Phase II to Study the Combination of Gemcitabine and Docetaxel in Patients With Locally Advanced or Metastatic Pancreatic or Biliary Adenocarcinoma That Cannot be Removed by Surgery |
Enrollment: | 45 |
Study Start Date: | August 2001 |
Estimated Study Completion Date: | December 2010 |
Arms | Assigned Interventions |
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unique: Experimental
Taxotère - Gemzar
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Drug: Docetaxel
Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines
Drug: Gemcitabine
Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines
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Try a new drug association on this advanced cancer
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | RIO PANCREAS |
Study First Received: | December 22, 2005 |
Last Updated: | September 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00268840 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Pancreas or biliary cancer |
Antimetabolites Biliary Tract Neoplasms Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Immunosuppressive Agents Antiviral Agents Pancrelipase Docetaxel |
Digestive System Diseases Radiation-Sensitizing Agents Biliary Tract Diseases Gastrointestinal Neoplasms Pancreatic Diseases Biliary Tract Cancer Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Docetaxel Neoplasms by Site Biliary Tract Diseases Therapeutic Uses Gemcitabine |
Endocrine Gland Neoplasms Digestive System Neoplasms Biliary Tract Neoplasms Endocrine System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases |