Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Cancer
Intervention: docetaxel (Drug); epirubicin hydrochloride (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) Official(s) and/or principal investigator(s): Christophe Louvet, MD, PhD, Affiliation: Hopital Saint Antoine
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.
Clinical Details
Official title: Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
Study design: Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Objective tumor response rateTime to tumor progression
Secondary outcome: Survival without local relapseOverall survival Tolerability
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): 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
Locations and Contacts
Centre Paul Papin, Angers 49036, France
Centre Hospitalier Victor Dupouy, Argenteuil 95107, France
Centre Hospital General Robert Ballanger, Aulnay Sous Bois 93602, France
C.H.G. Beauvais, Beauvais 60021, France
Clinique Tivoli, Bordeaux F-33000, France
Hopital Louis Pasteur, Chartres 28018, France
Hopital Drevon, Dijon 21000, France
Clinique Sainte-Marguerite, Hyeres 83400, France
Clinique Victor Hugo, Le Mans F-72000, France
Centre Hospital Universitaire Hop Huriez, Lille 59037, France
Clinique Saint Jean, Lyon 69008, France
Hopital de la Croix Rousse, Lyon 69317, France
CHU de la Timone, Marseille 13385, France
Intercommunal Hospital, Montfermeil 93370, France
American Hospital of Paris, Neuilly Sur Seine F-92202, France
Hopital Saint Antoine, Paris 75571, France
Hopital Saint Joseph, Paris 75674, France
Hopital Tenon, Paris 75970, France
Maison Medicale Marzet, Pau 64000, France
Hopital Rene Dubos, Pontoise 95300, France
C.H. Senlis, Senlis 60309, France
Hopital d'Instruction des Armes Sainte-Anne, Toulon 83800, France
CHRU de Tours - Hopital Trousseau, Tours 37044, France
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 2001
Last updated: July 23, 2008
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