RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.

Condition	Treatment or Intervention	Phase
stage III pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas	Drug: gemcitabine  Drug: oxaliplatin	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced or metastatic pancreatic carcinoma when treated with gemcitabine and oxaliplatin.

II. Determine the tolerablility and clinical benefit of this regimen in these patients.

III. Evaluate the progression free survival and the overall survival of these patients when treated with this regimen.

PROTOCOL OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV on day 1 over 1.5 hours and oxaliplatin IV over 2 hours on day 2. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with locally advanced disease receive 6-8 courses and then may undergo surgery, radiotherapy, and/or additional chemotherapy.

PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.

Ages Eligible for Study:  18 Years   -   75 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed metastatic or locally advanced unresectable adenocarcinoma of the pancreas
• Measurable disease; At least 2 cm in diameter
• No known brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: No prior immunotherapy
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: No concurrent corticosteroid use except as antiemetic
• Radiotherapy: No prior radiotherapy
• Surgery: Not specified
• Other: No other concurrent investigational drugs

--Patient Characteristics--

• Age: 18 to 75
• Performance status: ECOG 0-2 OR Karnofsky 60-100%
• Life expectancy: Greater than 12 weeks
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 5 times ULN
• Renal: Creatinine no greater than 1.5 times ULN
• Cardiovascular: Adequate cardiac function
• Pulmonary: Adequate respiratory function
• Other: Not pregnant or nursing; Fertile patients must use effective contraception; No sensitive neuropathy; No other active malignancy; No uncontrolled hypercalcemia; No significant medical or psychiatric condition that would preclude study; No psychological, familial, sociological, or geographical condition that would preclude study

Belgium
      Institut Jules Bordet, Brussels,  1000,  Belgium
France
      American Hospital of Paris, Neuilly-sur-Seine,  F-92202,  France
      Centre Hospitalier Victor Dupouy, Argenteuil,  95107,  France
      Centre Paul Papin, Angers,  49036,  France
      Clinique Saint Jean, Lyon,  69008,  France
      Hopital Beaujon, Clichy,  92118,  France
      Hopital Drevon, Dijon,  21000,  France
      Hopital Saint Antoine, Paris,  75571,  France
      Hopital Tenon, Paris,  75970,  France
      Polyclinique De Courlancy, Reims,  F-51100,  France

Study chairs or principal investigators

Christophe Louvet,  Study Chair,  GERCOR   

Study ID Numbers:  CDR0000068130; FRE-GERCOR-GEMOX-D99-2; EU-20027
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006117
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08