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

July 23, 2008 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49036
        • Centre Paul Papin
      • Argenteuil, France, 95107
        • centre hospitalier Victor Dupouy
      • Aulnay Sous Bois, France, 93602
        • Centre Hospital General Robert Ballanger
      • Beauvais, France, 60021
        • C.H.G. Beauvais
      • Bordeaux, France, F-33000
        • Clinique Tivoli
      • Chartres, France, 28018
        • Hôpital Louis Pasteur
      • Dijon, France, 21000
        • Hopital Drevon
      • Hyeres, France, 83400
        • Clinique Sainte-Marguerite
      • Le Mans, France, F-72000
        • Clinique Victor Hugo
      • Lille, France, 59037
        • Centre Hospital Universitaire Hop Huriez
      • Lyon, France, 69008
        • Clinique Saint Jean
      • Lyon, France, 69317
        • Hopital de la Croix Rousse
      • Marseille, France, 13385
        • CHU de la Timone
      • Montfermeil, France, 93370
        • Intercommunal Hospital
      • Neuilly Sur Seine, France, F-92202
        • American Hospital of Paris
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75571
        • Hôpital Saint Antoine
      • Paris, France, 75674
        • Hôpital Saint Joseph
      • Pau, France, 64000
        • Maison Medicale Marzet
      • Pontoise, France, 95300
        • Hôpital René Dubos
      • Senlis, France, 60309
        • C.H. Senlis
      • Toulon, France, 83800
        • Hopital d'Instruction des Armes Sainte-Anne
      • Tours, France, 37044
        • CHRU de Tours - Hopital Trousseau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

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

Hepatic

  • 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

Renal

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

Cardiovascular

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective tumor response rate
Time to tumor progression

Secondary Outcome Measures

Outcome Measure
Overall survival
Tolerability
Survival without local relapse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Christophe Louvet, MD, PhD, Hôpital Saint Antoine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 11, 2004

First Posted (Estimate)

January 12, 2004

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000346617
  • FRE-GERCOR-EPITAXD00-1
  • EU-20326

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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