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



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

For Condition: stage 3 gastric cancer,adenocarcinoma of the stomach,stage 4 gastric cancer
Status: Recruiting
Sponsor(s): GERCOR ,
Synopsis: 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 metastaticadenocarcinoma (cancer) of the stomach.
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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ChristopheLouvet,  ,  Hopital Saint Antoine

Intercommunal Hospital *Recruiting*
Montfermeil,  ,  93370
France
Recruiting Mostefa  Bennamoun 33-1-4850-1808

Hopital Drevon *Recruiting*
Dijon,  ,  21000
France
Recruiting Michel  Flesch 33-380-364-822

Clinique Tivoli *Recruiting*
Bordeaux,  ,  F-33030
France
Recruiting Dominique  Jaubert 33-556-116-087

Hopital Rene Dubos *Recruiting*
Pontoise,  ,  95300
France
Recruiting Frederique  Rosseau 33-1-3075-4040

Clinique de l'Esperance *Recruiting*
Hyeres,  ,  83400
France
Recruiting Jean  Berdah 33-4-9412-5555

Hopital Saint Antoine *Recruiting*
Paris,  ,  75571
France
Recruiting Christophe  Louvet 33-1-49-282-343

Hopital Fontenoy *Recruiting*
Chartres,  ,  28018
France
Recruiting Elizabeth  Angellier 33-2-373-03377

Clinique Victor Hugo *Recruiting*
Le Mans,  ,  F-72000
France
Recruiting Philippe  Solal-Celigny 33-2-4347-9493

CHU de la Timone *Recruiting*
Marseille,  ,  13385
France
Recruiting Jean  Seitz 33-4-9138-6000

C.H. Senlis *Recruiting*
Senlis,  ,  60309
France
Recruiting Elisabeth  Carola 33-3-4421-7000

Centre Hospital General Robert Ballanger *Recruiting*
Aulnay-sous-Bois,  ,  93602
France
Recruiting Claude  Boiron 33-1-4936-7123

Hopital de la Croix Rousse *Recruiting*
Lyon,  ,  69317
France
Recruiting Jean-Louis  Gaudin 33-4-7207-1609

Centre Hospitalier Victor Dupouy *Recruiting*
Argenteuil,  ,  95107
France
Recruiting Carole  Bouleuc 33-1-3423-2425

Hopital Saint Joseph *Recruiting*
Paris,  ,  75014
France
Recruiting Damien  Levoir 33-1-4412-3333

Maison Medicale Marzet *Recruiting*
Pau,  ,  64000
France
Recruiting Pierre  Marti 33-5-5992-7272

Centre Paul Papin *Recruiting*
Angers,  ,  49036
France
Recruiting Erick  Gamelin 33-2-4135-2700

Hopital Tenon *Recruiting*
Paris,  ,  75970
France
Recruiting Thierry  Andre 33-1-6177-0708

C.H.U. Armand Trousseau *Recruiting*
Paris,  ,  75571
France
Recruiting Etienne  Dorval 33-1-4473-7475

American Hospital of Paris *Recruiting*
Neuilly-sur-Seine,  ,  F-92202
France
Recruiting Bertrand  Callet 33-1-4641-2525

Hopital d'Instruction des Armes Sainte-Anne *Recruiting*
Toulon,  ,  83800
France
Recruiting  Ciribilli 33-4-9409-9000

Clinique Saint Jean *Recruiting*
Lyon,  ,  69008
France
Recruiting Gerard  Gledo 33-4-7878-1010

Centre Hospital Universitaire Hop Huriez *Recruiting*
Lille,  ,  59037
France
Recruiting Stephane  Cattan 33-3-2044-5962

C.H.G. Beauvais *Recruiting*
Beauvais,  ,  60021
France
Recruiting J.L.  Dutel 33-344-112-309


Additional Information:
Study ID Numbers:
  CDR0000346617;  EU-20326,FRE-GERCOR-EPITAXD00-1
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075465

Other Adenocarcinoma Of The Stomach Studies:
1. Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach

2. Oxaliplatin With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach

3. Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

4. Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction

5. Imatinib Mesylate in Treating Patients With Refractory Metastatic and/or Unresectable Stomach Cancer

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

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