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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining docetaxel with epirubicin as first-line therapy in treating patients who have locally advanced or metastatic adenocarcinoma (cancer) of the stomach.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the stomach stage III gastric cancer stage IV gastric cancer	Drug: docetaxel  Drug: epirubicin  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Christophe Louvet, MD, PhD,  Hopital Saint Antoine   

Study ID Numbers:  CDR0000346617; FRE-GERCOR-EPITAXD00-1; EU-20326; NCT00075465
Record last reviewed:  December 2003
Last Updated:  April 4, 2005
Record first received:  January 9, 2004
ClinicalTrials.gov Identifier:  NCT00075465
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08