Clinical trial NCT00075465: Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
Official title: Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: adenocarcinoma of the stomach
stage III gastric cancer
stage IV gastric cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-01-12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Objective tumor response rate
measure: Time to tumor progression
Secondary outcomes:
measure: Survival without local relapse
measure: Overall survival
measure: Tolerability
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Aulnay Sous Bois
country: France
facility: Centre Hospital General Robert Ballanger
city: Beauvais
country: France
facility: C.H.G. Beauvais
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Chartres
country: France
facility: Hopital Louis Pasteur
city: Dijon
country: France
facility: Hopital Drevon
city: Hyeres
country: France
facility: Clinique Sainte-Marguerite
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille
country: France
facility: Centre Hospital Universitaire Hop Huriez
city: Lyon
country: France
facility: Clinique Saint Jean
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Marseille
country: France
facility: CHU de la Timone
city: Montfermeil
country: France
facility: Intercommunal Hospital
city: Neuilly Sur Seine
country: France
facility: American Hospital of Paris
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Saint Joseph
city: Paris
country: France
facility: Hopital Tenon
city: Pau
country: France
facility: Maison Medicale Marzet
city: Pontoise
country: France
facility: Hopital Rene Dubos
city: Senlis
country: France
facility: C.H. Senlis
city: Toulon
country: France
facility: Hopital d'Instruction des Armes Sainte-Anne
city: Tours
country: France
facility: CHRU de Tours - Hopital Trousseau
Study officials:
affiliation: Hopital Saint Antoine
name: Christophe Louvet, MD, PhD
References: