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Home > "G" Clinical Trials Conditions > Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma



Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

For Condition: stage 2 pancreatic cancer,adenocarcinoma of the pancreas,stage 4B pancreatic cancer,stage 3 pancreatic cancer,stage 4A pancreatic cancer
Status: Recruiting
Sponsor(s): GERCOR ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreaticadenocarcinoma. PURPOSE: Randomizedphase III trial to compare the effectiveness of gemcitabine with or without oxaliplatin in treating patients who have locally advanced or metastaticunresectable pancreatic adenocarcinoma.
Details: OBJECTIVES: Primary - Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin. Secondary - Compare the time of response in patients treated with these regimens. - Compare the clinical benefit of and tolerance to these regimens in these patients. - Compare the quality of life of patients treated with these regimens. - Compare the progression-free survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity. After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy. Quality of life is assessed at baseline and then every 2 months. PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed pancreatic adenocarcinoma - Locally advanced or metastatic disease - Unresectable disease - Measurable disease - At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner - No adenocarcinoma of the bile ducts or ampulla of Vater - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 12 weeks Hematopoietic - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic - Bilirubin less than 1.5 times normal - Alkaline phosphatase less than 5 times normal Renal - Creatinine less than 1.5 times normal - No uncontrolled or persistent hypercalcemia Cardiovascular - No serious cardiac failure Pulmonary - No serious respiratory failure Other - Pain must be stabilized or controlled before initiation of study treatment - Not pregnant or nursing - Fertile patients must use effective contraception - No other untreatable malignant tumor - No serious psychological, familial, social, or geographical condition that would preclude study participation - No neuropathy that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - No concurrent corticosteroids except for antiemetic therapy Radiotherapy - No prior radiotherapy Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ChristopheLouvet,  ,  Hopital Saint Antoine

Hopital Beaujon *Recruiting*
Clichy,  ,  92118
France
Recruiting P.  Hammel 33-14-087-5653

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

Hopital Haut Leveque *Recruiting*
Pessac,  ,  33604
France
Recruiting Jean-Louis  Legoux 335-5765-6438

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

CMC Bligny *Recruiting*
Briis-sous-Forges,  ,  91640
France
Recruiting Marie-Christine  Clavero-Fabri 33-1-6490-7005

C. H. De Saumur *Recruiting*
Saumur,  ,  49403
France
Recruiting Michel  Maigre 33-2-4153-3030

Hopital Bichat - Claude Bernard *Recruiting*
Paris,  ,  75018
France
Recruiting Thomas  Aparicio 33-01-4025-7000

Hopital Saint - Louis *Recruiting*
La Rochelle,  ,  17000
France
Recruiting  Paitel 33-546-455321

CHU Pitie-Salpetriere *Recruiting*
Paris,  ,  75651
France
Recruiting Bernard  Brun 33-1-142-178-176

Hopital Notre-Dame de Bon Secours *Recruiting*
Metz,  ,  57038
France
Recruiting Sabine  Walter 33-387-553-554

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

CHU Ambroise Pare *Recruiting*
Boulogne-Billancourt,  ,  F-92104
France
Recruiting Philippe  Rougier 33-01-49-095-325

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

Hopital Robert Boulin *Recruiting*
Libourne,  ,  33500
France
Recruiting Dominique  Auby 33-05-5755-3552

Centre Hospitalier Departemental *Recruiting*
La Roche-sur-Yon,  ,  F-85025
France
Recruiting Roger  Faroux 33-02-5144-6168

Clinique Ste - Marie *Recruiting*
Pontoise,  ,  95300
France
Recruiting Marie-Helene  Filippi 33-01-3038-5805

Hopital Andre Mignot *Recruiting*
Le Chesnay,  ,  78157
France
Recruiting Jacques  Doll 33-01-3963-8901

Hopital de la Croix St. Simon *Recruiting*
Paris,  ,  75020
France
Recruiting Isabelle  Cojean-Zelek 33-1-4464-1600

Hopital Saint Andre *Recruiting*
Bordeaux,  ,  33075
France
Recruiting Denis  Smith 33-5-5679-5679

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

Centre Hospitalier Lyon Sud *Recruiting*
Pierre-Benite,  ,  69495
France
Recruiting Gilles  Salles 33-478-861-191

Hopital Louis Mourier *Recruiting*
Colombes,  , 
France
Recruiting Jean-Luc  Molitor 33-1-47-60-60-73

Centre Hospitalier de Lagny *Recruiting*
Lagny Sur Marne,  ,  77405
France
Recruiting Annie  Bellaiche 33-01-6430-7048

Chu-Hopital Gabriel Montpied *Recruiting*
Clermont-Ferrand,  ,  F-63000
France
Recruiting  Ointcloux 33-4-7362-5700

Polyclinique De Courlancy *Recruiting*
Reims,  ,  F-51100
France
Recruiting Philippe  Colin 33-3-2684-0284

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

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

Hopital Saint-Louis *Recruiting*
Paris,  ,  75475
France
Recruiting Christophe  Hennequin 33-1-4249-4949

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

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

Hopital Europeen Georges Pompidou *Recruiting*
Paris,  ,  75015
France
Recruiting Bruno  Landi 33-1-5609-3555

Centre Jean Bernard *Recruiting*
Le Mans,  ,  72000
France
Recruiting Gerard  Ganem 334-339-1300

Centre Hospital Universitaire Hop Huriez *Recruiting*
Lille,  ,  59037
France
Recruiting Mohamed  Hebbar 33-3-2044-5479

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

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

Institut Gustave Roussy *Recruiting*
Villejuif,  ,  F-94805
France
Recruiting Michel  Ducreux 33-1-4211-4308

C. H. Du Mans *Recruiting*
Le Mans,  ,  72037
France
Recruiting Marie-Aude  Coulon 33-2-4343-4343

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


Additional Information:
Study ID Numbers:
  CDR0000346480;  EU-20324,FRE-GERCOR-GEM-GEMOX/D00-3
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075452

Other Stage 3 Pancreatic Cancer Studies:
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2. Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach

3. Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer

4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer

5. UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

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