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

Gastric Cancer Clinical Trial

Official title:

Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00075465
• Other study ID #: CDR0000346617
• Secondary ID: FRE-GERCOR-EPITA
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 9, 2004
• Last updated: July 23, 2008
• Start date: April 2001

Study information

• Verified date: July 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• docetaxel

• epirubicin hydrochloride

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Hospitalier Victor Dupouy	Argenteuil
France	Centre Hospital General Robert Ballanger	Aulnay Sous Bois
France	C.H.G. Beauvais	Beauvais
France	Clinique Tivoli	Bordeaux
France	Hopital Louis Pasteur	Chartres
France	Hopital Drevon	Dijon
France	Clinique Sainte-Marguerite	Hyeres
France	Clinique Victor Hugo	Le Mans
France	Centre Hospital Universitaire Hop Huriez	Lille
France	Clinique Saint Jean	Lyon
France	Hopital de la Croix Rousse	Lyon
France	CHU de la Timone	Marseille
France	Intercommunal Hospital	Montfermeil
France	American Hospital of Paris	Neuilly Sur Seine
France	Hopital Saint Antoine	Paris
France	Hopital Saint Joseph	Paris
France	Hopital Tenon	Paris
France	Maison Medicale Marzet	Pau
France	Hopital Rene Dubos	Pontoise
France	C.H. Senlis	Senlis
France	Hopital d'Instruction des Armes Sainte-Anne	Toulon
France	CHRU de Tours - Hopital Trousseau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response rate			No
Primary	Time to tumor progression			No
Secondary	Survival without local relapse			No
Secondary	Overall survival			No
Secondary	Tolerability			Yes