Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach

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: NCT00075465
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2004
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the stomach.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: docetaxel Drug: epirubicin hydrochloride Phase 2

Detailed Description:



  • Determine the objective tumor response rate and time to tumor progression in patients with locally advanced or metastatic adenocarcinoma of the stomach treated with docetaxel and epirubicin as first-line therapy.


  • Determine the survival without local relapse and overall survival of patients treated with this regimen.
  • Determine the tolerance to this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
Study Start Date : April 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Objective tumor response rate
  2. Time to tumor progression

Secondary Outcome Measures :
  1. Survival without local relapse
  2. Overall survival
  3. Tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the stomach

    • Locally advanced or metastatic disease
  • Measurable disease

    • At least 1 unidimensionally measurable target lesion at least 2 cm in diameter
  • No known symptomatic brain metastases
  • No bone metastases



  • 18 to 75

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin less than 2 times normal
  • AST and ALT no greater than 2.5 times normal
  • Alkaline phosphatase no greater than 2.5 times normal


  • Creatinine less than 1.6 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No serious cardiac failure within the past 12 months
  • No myocardial infarction within the past 12 months
  • No cardiac insufficiency
  • No angina


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No uncontrolled serious infection
  • No significant brain or psychiatric disorders
  • No intolerance to cortisone or polysorbate 80
  • No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No other illness or medical condition that would preclude study participation
  • No peripheral neuropathy greater than grade 2


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • More than 21 days since prior participation in another clinical study
  • No other concurrent experimental medication

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): NCT00075465

Centre Paul Papin
Angers, France, 49036
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Centre Hospital General Robert Ballanger
Aulnay Sous Bois, France, 93602
C.H.G. Beauvais
Beauvais, France, 60021
Clinique Tivoli
Bordeaux, France, F-33000
Hopital Louis Pasteur
Chartres, France, 28018
Hopital Drevon
Dijon, France, 21000
Clinique Sainte-Marguerite
Hyeres, France, 83400
Clinique Victor Hugo
Le Mans, France, F-72000
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Clinique Saint Jean
Lyon, France, 69008
Hopital de la Croix Rousse
Lyon, France, 69317
CHU de la Timone
Marseille, France, 13385
Intercommunal Hospital
Montfermeil, France, 93370
American Hospital of Paris
Neuilly Sur Seine, France, F-92202
Hopital Saint Antoine
Paris, France, 75571
Hopital Saint Joseph
Paris, France, 75674
Hopital Tenon
Paris, France, 75970
Maison Medicale Marzet
Pau, France, 64000
Hopital Rene Dubos
Pontoise, France, 95300
C.H. Senlis
Senlis, France, 60309
Hopital d'Instruction des Armes Sainte-Anne
Toulon, France, 83800
CHRU de Tours - Hopital Trousseau
Tours, France, 37044
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
OverallOfficial: Christophe Louvet, MD, PhD Hopital Saint Antoine Identifier: NCT00075465     History of Changes
Other Study ID Numbers: CDR0000346617
First Posted: January 12, 2004    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: July 2007

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the stomach
stage III gastric cancer
stage IV gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors