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The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268840
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : June 30, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Neoplasms Biliary Tract Neoplasms Drug: Docetaxel Drug: Gemcitabine Phase 2

Detailed Description:
Try a new drug association on this advanced cancer

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2001
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Arm Intervention/treatment
Experimental: unique
Taxotère - Gemzar
Drug: Docetaxel
Docetaxel 50 mg/m2 ou 35 mg/m² (suivant le bilan hépatique) à J1 et J15 toutes les 4 semaines
Other Name: TAXOTERE

Drug: Gemcitabine
Gemcitabine 1200 mg/m2 à J1 et J15 toutes les 4 semaines
Other Name: GEMZAR

Primary Outcome Measures :
  1. Overall response rate

Secondary Outcome Measures :
  1. Clinical benefit
  2. Progression-free survival
  3. Overall survival
  4. To evaluate the frequency and severity of the adverse events related to the combination of gemcitabine and docetaxel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 18 years or older
  • Patients must sign informed consent prior to study entry
  • Patients has Karnofsky performance status of more than 50%
  • No prior chemotherapy
  • Histologically or cytologically confirmed adenocarcinoma of the pancreas, locally advanced or metastatic disease or biliary cancer
  • No previous radiotherapy for locally advanced or metastases.
  • Hematopoietic: WBC > 3000/mm2, Absolute neutrophile count > 1500/mm2, Hemoglobin > 9g/dl, Platelet count > 100 000/mm2

Exclusion Criteria:

  • No intracerebral or meningeal metastases
  • Pregnant
  • Fertile patient must use effective contraception
  • No other serious medical condition or illness that would preclude study participation
  • Hepatic: Bilirubin greater than upper limit of normal(ULN) SGOT and SGPT > 3.5 times upper limit of normal(ULN) alkaline phosphatase > 6 times upper limit of normal(ULN)
  • More than 30 days since prior investigational therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268840

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Hôpital Hôtel Dieu
Paris, France, 75004
Sponsors and Collaborators
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Study Chair: Chauvenet Laure, MD ARCAGY/ GINECO GROUP

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Responsible Party: Benedicte VOTAN, ARCAGY-GINECO Identifier: NCT00268840     History of Changes
Other Study ID Numbers: RIO PANCREAS
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: June 2011
Keywords provided by ARCAGY/ GINECO GROUP:
Pancreas or biliary cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators