RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.

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

Further Study Details: 

OBJECTIVES: Primary

• Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs gemcitabine as first-line chemotherapy. (Phase II)
• Compare the survival of patients treated with these regimens. (Phase III)

Secondary

• Compare the toxicity of these regimens in these patients.
• Compare progression-free survival of patients treated with these regimens. (Phase III)
• Compare the overall response rate in patients treated with these regimens. (Phase III)
• Compare quality of life of patients treated with these regimens. (Phase III)

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oxaliplatin IV over 2 hours, irinotecan IV over 1½ hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days.
• Arm II: Patients receive gemcitabine IV on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 57, patients receive gemcitabine IV once weekly for 3 weeks (days 57, 64, and 71). Courses repeat every 28 days.

PROJECTED ACCRUAL: A total of 348 patients (88 for phase II and 260 for phase III) will be accrued for this study.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• No other pancreatic tumor type, including either of the following:
• Neuroendocrine tumor
• Acinar cell tumor
• Metastatic disease
• Measurable disease in an area not previously irradiated
• No cerebral metastases or meningeal involvement of the tumor

PATIENT CHARACTERISTICS: Age

• 18 to 75

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed)

Renal

• Creatinine < 120 mmol/L

Cardiovascular

• No prior myocardial infarction
• No prior angina
• No uncompensated cardiac or coronary insufficiency
• No symptomatic arrhythmia

Gastrointestinal

• No prior inflammatory bowel disease
• No prior chronic diarrhea
• No unresolved symptomatic occlusion or subocclusion of the bowel

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No ongoing active infection
• No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No contraindication to study treatment
• No other serious medical disorder that would preclude study treatment
• No psychiatric disorder or social or geographic situation that would preclude study participation
• Not detained or under the guardianship of another person

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Other

• No concurrent participation in another clinical trial using therapeutic experimental agents

Please refer to this study by ClinicalTrials.gov identifier  NCT00112658

France
      Centre Alexis Vautrin, Vandoeuvre-les-Nancy,  54511,  France; Recruiting
      Centre Eugene Marquis, Rennes,  35064,  France; Recruiting
      Centre Hospitalier Universitaire Henri Mondor, Creteil,  94010,  France; Recruiting
      Centre Hospitalier Universitaire, Reims,  51092,  France; Recruiting
      Centre Jean Perrin, Clermont-Ferrand,  63011,  France; Recruiting
      Centre Leon Berard, Lyon,  69373,  France; Recruiting
      Centre Oscar Lambret, Lille,  59020,  France; Recruiting
      Centre Regional de Lutte Contre le Cancer - Centre Val d''''Aurelle, Montpellier,  34298,  France; Recruiting
      Centre Regional Francois Baclesse, Caen,  14076,  France; Recruiting
      Centre Regional Rene Gauducheau, Nantes-Saint Herblain,  44805,  France; Recruiting
      Centre Rene Huguenin, Saint Cloud,  92210,  France; Recruiting
      CHR de Besancon - Hopital Jean Minjoz, Besancon,  25030,  France; Recruiting
      Hopital Charles Nicolle, Rouen,  76031,  France; Recruiting
      Hopital Saint Joseph, Paris,  75674,  France; Recruiting
      Institut Bergonie, Bordeaux,  33076,  France; Recruiting
      Institut Claudius Regaud, Toulouse,  31052,  France; Recruiting
      Institut Gustave Roussy, Villejuif,  F-94805,  France; Recruiting
      Institut Jean Godinot, Reims,  51056,  France; Recruiting

Study chairs or principal investigators

Thierry Conroy, MD,  Study Chair,  Centre Alexis Vautrin   

Study ID Numbers:  CDR0000430100; FRE-FNCLCC-ACCORD-11/0402; EU-20512
Record last reviewed:  May 2005
Last Updated:  June 2, 2005
Record first received:  June 2, 2005
ClinicalTrials.gov Identifier:  NCT00112658
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07