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Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma Clinical research trials and Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including 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 Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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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:
1. Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
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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Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
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