NCT00075465

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

23 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2004

Completed
Last Updated

July 24, 2008

Status Verified

July 1, 2007

First QC Date

January 9, 2004

Last Update Submit

July 23, 2008

Conditions

Gastric Cancer

Keywords

adenocarcinoma of the stomachstage III gastric cancerstage IV gastric cancer

Outcome Measures

Primary Outcomes (2)

  • Objective tumor response rate

  • Time to tumor progression

Secondary Outcomes (3)

  • Survival without local relapse

  • Overall survival

  • Tolerability

Interventions

docetaxelDRUG
epirubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (23)

Centre Paul Papin

Angers, 49036, France

Location

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Centre Hospital General Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Clinique Tivoli

Bordeaux, F-33000, France

Location

Hopital Louis Pasteur

Chartres, 28018, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Clinique Sainte-Marguerite

Hyères, 83400, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Clinique Saint Jean

Lyon, 69008, France

Location

Hopital de la Croix Rousse

Lyon, 69317, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Intercommunal Hospital

Montfermeil, 93370, France

Location

American Hospital of Paris

Neuilly-sur-Seine, F-92202, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Saint Joseph

Paris, 75674, France

Location

Hopital Tenon

Paris, 75970, France

Location

Maison Medicale Marzet

Pau, 64000, France

Location

Hopital Rene Dubos

Pontoise, 95300, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Hopital d'Instruction des Armes Sainte-Anne

Toulon, 83800, France

Location

CHRU de Tours - Hopital Trousseau

Tours, 37044, France

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

DocetaxelEpirubicin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Christophe Louvet, MD, PhD

    Hopital Saint Antoine

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 12, 2004

Study Start

April 1, 2001

Last Updated

July 24, 2008

Record last verified: 2007-07

Locations

FR(23)