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Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
This study is ongoing, but not recruiting participants.
First Received: January 9, 2004   Last Updated: July 23, 2008   History of Changes
Sponsored by: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075465
  Purpose

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 Intervention Phase
Gastric Cancer
 Drug: docetaxel
Drug: epirubicin hydrochloride
 Phase II

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Epirubicin hydrochloride Epirubicin Docetaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective tumor response rate [ Designated as safety issue: No ]
  • Time to tumor progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival without local relapse [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]

Study Start Date: April 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075465

Locations
France
American Hospital of Paris
Neuilly Sur Seine, France, F-92202
C.H. Senlis
Senlis, France, 60309
C.H.G. Beauvais
Beauvais, France, 60021
Centre Hospital General Robert Ballanger
Aulnay Sous Bois, France, 93602
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Centre Paul Papin
Angers, France, 49036
CHRU de Tours - Hopital Trousseau
Tours, France, 37044
CHU de la Timone
Marseille, France, 13385
Clinique Saint Jean
Lyon, France, 69008
Clinique Sainte-Marguerite
Hyeres, France, 83400
Maison Medicale Marzet
Pau, France, 64000
Clinique Victor Hugo
Le Mans, France, F-72000
Hopital de la Croix Rousse
Lyon, France, 69317
Hopital d'Instruction des Armes Sainte-Anne
Toulon, France, 83800
Hopital Drevon
Dijon, France, 21000
Hopital Louis Pasteur
Chartres, France, 28018
Hopital Rene Dubos
Pontoise, France, 95300
Hopital Saint Antoine
Paris, France, 75571
Hopital Saint Joseph
Paris, France, 75674
Hopital Tenon
Paris, France, 75970
Intercommunal Hospital
Montfermeil, France, 93370
Clinique Tivoli
Bordeaux, France, F-33000
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Investigator: Christophe Louvet, MD, PhD Hopital Saint Antoine
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000346617, FRE-GERCOR-EPITAXD00-1, EU-20326
Study First Received: January 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00075465     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Epirubicin
Carcinoma
Docetaxel
Anti-Bacterial Agents
Digestive System Diseases
 Stomach Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach Cancer
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Digestive System Neoplasms
Antineoplastic Agents
Gastrointestinal Diseases
Antibiotics, Antineoplastic
Epirubicin
Pharmacologic Actions
Carcinoma
Docetaxel
 Neoplasms
Neoplasms by Site
Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Stomach Neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009



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