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: Randomized phase III trial to compare the effectiveness of gemcitabine with or without oxaliplatin in treating patients who have locally advanced or metastatic unresectable pancreatic adenocarcinoma.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the pancreas stage II pancreatic cancer stage III pancreatic cancer stage IVA pancreatic cancer stage IVB pancreatic cancer	Drug: gemcitabine  Drug: oxaliplatin  Procedure: chemotherapy	Phase III

Further Study 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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

France
      American Hospital of Paris, Neuilly-sur-Seine,  F-92202,  France; Recruiting
      C. H. De Saumur, Saumur,  49403,  France; Recruiting
      C. H. Du Mans, Le Mans,  72037,  France; Recruiting
      C.H. Senlis, Senlis,  60309,  France; Recruiting
      C.H.G. Beauvais, Beauvais,  60021,  France; Recruiting
      Centre Hospital Universitaire Hop Huriez, Lille,  59037,  France; Recruiting
      Centre Hospitalier de Lagny, Lagny Sur Marne,  77405,  France; Recruiting
      Centre Hospitalier Departemental, La Roche-sur-Yon,  F-85025,  France; Recruiting
      Centre Hospitalier Lyon Sud, Pierre-Benite,  69495,  France; Recruiting
      Centre Jean Bernard, Le Mans,  72000,  France; Recruiting
      Centre Paul Papin, Angers,  49036,  France; Recruiting
      CHU Ambroise Pare, Boulogne-Billancourt,  F-92104,  France; Recruiting
      CHU Pitie-Salpetriere, Paris,  75651,  France; Recruiting
      Chu-Hopital Gabriel Montpied, Clermont-Ferrand,  F-63000,  France; Recruiting
      Clinique Saint Jean, Lyon,  69008,  France; Recruiting
      Clinique Ste - Marie, Pontoise,  95300,  France; Recruiting
      CMC Bligny, Briis-sous-Forges,  91640,  France; Recruiting
      Hopital Andre Mignot, Le Chesnay,  78157,  France; Recruiting
      Hopital Beaujon, Clichy,  92118,  France; Recruiting
      Hopital Bichat - Claude Bernard, Paris,  75018,  France; Recruiting
      Hopital de la Croix Rousse, Lyon,  69317,  France; Recruiting
      Hopital de la Croix St. Simon, Paris,  75020,  France; Recruiting
      Hopital Drevon, Dijon,  21000,  France; Recruiting
      Hopital Europeen Georges Pompidou, Paris,  75015,  France; Recruiting
      Hopital Haut Leveque, Pessac,  33604,  France; Recruiting
      Hopital Louis Mourier, Colombes,  F-92701,  France; Recruiting
      Hopital Louis Pasteur, Chartres,  28018,  France; Recruiting
      Hopital Notre-Dame de Bon Secours, Metz,  57038,  France; Recruiting
      Hopital Robert Boulin, Libourne,  33500,  France; Recruiting
      Hopital Saint - Louis, La Rochelle,  17000,  France; Recruiting
      Hopital Saint Andre, Bordeaux,  33075,  France; Recruiting
      Hopital Saint Antoine, Paris,  75571,  France; Recruiting
      Hopital Saint-Louis, Paris,  75475,  France; Recruiting
      Hopital Tenon, Paris,  75970,  France; Recruiting
      Institut Gustave Roussy, Villejuif,  F-94805,  France; Recruiting
      Intercommunal Hospital, Montfermeil,  93370,  France; Recruiting
      Maison Medicale Marzet, Pau,  64000,  France; Recruiting
      Polyclinique De Courlancy, Reims,  F-51100,  France; Recruiting

Study chairs or principal investigators

Christophe Louvet, MD, PhD,  Hopital Saint Antoine   

Study ID Numbers:  CDR0000346480; FRE-GERCOR-GEM-GEMOX/D00-3; EU-20324; NCT00075452
Record last reviewed:  December 2003
Last Updated:  March 3, 2005
Record first received:  January 9, 2004
ClinicalTrials.gov Identifier:  NCT00075452
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08