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

First Received on January 9, 2004. Last Updated on July 23, 2008 History of Changes

Sponsor:	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

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:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Epirubicin hydrochloride Epirubicin Docetaxel

U.S. FDA Resources

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
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:

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

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:

Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Epirubicin
Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012