Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
NCT ID: NCT00075452
Last Updated: 2008-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
2003-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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gemcitabine hydrochloride
oxaliplatin
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Principal Investigators
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Christophe Louvet, MD, PhD
Role:
Hopital Saint Antoine
Locations
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Centre Paul Papin
Angers, , France
C.H.G. Beauvais
Beauvais, , France
Hopital Saint Andre
Bordeaux, , France
CHU Ambroise Pare
Boulogne-Billancourt, , France
CMC Bligny
Briis-sous-Forges, , France
Hopital Louis Pasteur
Chartres, , France
Chu-Hopital Gabriel Montpied
Clermont-Ferrand, , France
Hopital Beaujon
Clichy, , France
Hopital Louis Mourier
Colombes, , France
Hopital Drevon
Dijon, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Hopital Saint - Louis
La Rochelle, , France
Centre Hospitalier de Lagny
Lagny-sur-Marne, , France
Hopital Andre Mignot
Le Chesnay, , France
Centre Jean Bernard
Le Mans, , France
C. H. Du Mans
Le Mans, , France
Hopital Robert Boulin
Libourne, , France
Centre Hospital Universitaire Hop Huriez
Lille, , France
Clinique Saint Jean
Lyon, , France
Hopital de la Croix Rousse
Lyon, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Intercommunal Hospital
Montfermeil, , France
American Hospital of Paris
Neuilly-sur-Seine, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Bichat - Claude Bernard
Paris, , France
Hopital de la Croix St. Simon
Paris, , France
Hopital Saint-Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Hopital Tenon
Paris, , France
Maison Medicale Marzet
Pau, , France
Hopital Haut Leveque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Clinique Ste - Marie
Pontoise, , France
Polyclinique De Courlancy
Reims, , France
C. H. De Saumur
Saumur, , France
C.H. Senlis
Senlis, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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.
Other Identifiers
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FRE-GERCOR-GEM-GEMOX/D00-3
Identifier Type: -
Identifier Source: secondary_id
EU-20324
Identifier Type: -
Identifier Source: secondary_id
CDR0000346480
Identifier Type: -
Identifier Source: org_study_id