- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00075452
Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
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 pancreatic adenocarcinoma.
PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Angers, France, 49036
- Centre Paul Papin
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Beauvais, France, 60021
- C.H.G. Beauvais
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Bordeaux, France, 33075
- Hopital Saint André
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Boulogne Billancourt, France, F-92104
- CHU Ambroise Paré
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Briis Sous Forges, France, 91640
- CMC Bligny
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Chartres, France, 28018
- Hôpital Louis Pasteur
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Clermont Ferrand, France, F-63000
- CHU-Hopital Gabriel Montpied
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Clichy, France, 92118
- Hopital Beaujon
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Colombes, France, F-92701
- Hopital Louis Mourier
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Dijon, France, 21000
- Hopital Drevon
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La Roche Sur Yon, France, F-85025
- Centre Hospitalier departemental
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La Rochelle, France, 17000
- Hopital Saint - Louis
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Lagny Sur Marne, France, 77405
- Centre Hospitalier de Lagny
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Le Chesnay, France, 78157
- Hopital Andre Mignot
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Le Mans, France, 72000
- Centre Jean Bernard
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Le Mans, France, 72037
- C. H. Du Mans
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Libourne, France, 33500
- Hôpital Robert Boulin
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Lille, France, 59037
- Centre Hospital Universitaire Hop Huriez
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Lyon, France, 69008
- Clinique Saint Jean
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Lyon, France, 69317
- Hopital de La Croix Rousse
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Metz, France, 57038
- Hopital Notre-Dame de Bon Secours
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Montfermeil, France, 93370
- Intercommunal Hospital
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Neuilly Sur Seine, France, F-92202
- American Hospital of Paris
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Paris, France, 75015
- Hôpital Européen Georges Pompidou
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Paris, France, 75018
- Hôpital Bichat - Claude Bernard
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Paris, France, 75651
- CHU Pitié-Salpétrière
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Paris, France, 75970
- Hopital Tenon
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Paris, France, 75571
- Hopital Saint Antoine
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Paris, France, 75475
- Hopital Saint-Louis
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Paris, France, 75020
- Hopital de la Croix St. Simon
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Pau, France, 64000
- Maison Medicale Marzet
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Pessac, France, 33604
- Hopital Haut Leveque
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Pierre Benite, France, 69495
- Centre Hospitalier Lyon Sud
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Pontoise, France, 95300
- Clinique Ste - Marie
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Reims, France, F-51100
- Polyclinique de Courlancy
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Saumur, France, 49403
- C. H. De Saumur
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Senlis, France, 60309
- C.H. Senlis
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Villejuif, France, F-94805
- Institut Gustave Roussy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Overall survival
|
Secondary Outcome Measures
Outcome Measure |
---|
Progression-free survival
|
Quality of life
|
Time to response
|
Clinical benefit
|
Collaborators and Investigators
Investigators
- Christophe Louvet, MD, PhD, Hopital Saint Antoine
Publications and helpful links
General Publications
- Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31. doi: 10.1200/JCO.2006.07.5663.
- Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, Andre T, Zaniboni A, Ducreux M, Aitini E, Taieb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. doi: 10.1200/JCO.2005.06.023.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Oxaliplatin
Other Study ID Numbers
- CDR0000346480
- FRE-GERCOR-GEM-GEMOX/D00-3
- EU-20324
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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