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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.
Sponsor:
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00268840
First received: December 22, 2005
Last updated: June 29, 2011
Last verified: June 2011
History of Changes

December 22, 2005
June 29, 2011
August 2001
February 2006   (final data collection date for primary outcome measure)
Overall response rate
Overall reponse rate
Complete list of historical versions of study NCT00268840 on ClinicalTrials.gov Archive Site
  • 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
  • -Clinical benifit
  • -Progression -free survival
  • -Overall survival
  • -To evaluate the frequency and severity of the adverses events related to the combinaison of gemcitabine and docetaxel
Not Provided
Not Provided
 
The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer
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

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.

Try a new drug association on this advanced cancer
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Neoplasms
  • Biliary Tract Neoplasms
  • 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
Experimental: unique
Taxotère - Gemzar
Interventions:
  • Drug: Docetaxel
  • Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
February 2006
February 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00268840
RIO PANCREAS
No
Benedicte VOTAN, ARCAGY-GINECO
ARCAGY/ GINECO GROUP
Not Provided
Study Chair: Chauvenet Laure, MD ARCAGY/ GINECO GROUP
ARCAGY/ GINECO GROUP
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP