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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075465
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: July 2007
  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 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


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
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: NCT00075465

Locations
France
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
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Investigator: Christophe Louvet, MD, PhD Hopital Saint Antoine
  More Information

Additional Information:
No publications provided

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

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

ClinicalTrials.gov processed this record on September 16, 2014