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

This study has been completed.
Information provided by:
First received: December 22, 2005
Last updated: June 29, 2011
Last verified: June 2011
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
Pancreatic Neoplasms Biliary Tract Neoplasms Drug: Docetaxel Drug: Gemcitabine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • Overall response rate

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

Enrollment: 45
Study Start Date: August 2001
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00268840

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

Responsible Party: Benedicte VOTAN, ARCAGY-GINECO Identifier: NCT00268840     History of Changes
Other Study ID Numbers: RIO PANCREAS
Study First Received: December 22, 2005
Last Updated: June 29, 2011

Keywords provided by ARCAGY/ GINECO GROUP:
Pancreas or biliary cancer

Additional relevant MeSH terms:
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 processed this record on September 21, 2017