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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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268840

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

No publications provided

Responsible Party: Benedicte VOTAN, ARCAGY-GINECO
ClinicalTrials.gov Identifier: NCT00268840     History of Changes
Other Study ID Numbers: RIO PANCREAS
Study First Received: December 22, 2005
Last Updated: June 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Neoplasms
Pancreatic Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Site
Pancreatic Diseases
Docetaxel
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014