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 and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas.

Condition	Treatment or Intervention	Phase
stage III pancreatic cancer adenocarcinoma of the pancreas stage IVA pancreatic cancer stage IVB pancreatic cancer	Drug: cisplatin  Drug: fluorouracil  Procedure: chemotherapy	Phase III

Further Study Details: 

OBJECTIVES:

• Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer.
• Test the value of adding cisplatin to fluorouracil in extending survival in these patients.

OUTLINE: This is a multicenter, randomized study.

The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment groups involving the use or absence of chronomodulation and cisplatin (CDDP). Treatment in each of the 4 groups is repeated for 3 courses where each course is a 5-day course of treatment.

Patients in the first group receive a chronomodulated schedule based on delivery of fluorouracil (FU). Patients in the second group receive a chronomodulated schedule of FU and CDDP. Patients in the third and fourth experimental groups receive flat schedules of FU alone or FU and CDDP, respectively. Dosages of FU are increased across the three courses whereas dosages of CDDP remain constant.

Treatment is continued until disease progression, severe toxicity, or complete remission for more than 4 months occurs.

PROJECTED ACCRUAL: 200 patients will be accrued.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologic or cytologic proof of adenocarcinoma of the exocrine pancreas or of a metastasis associated with a radiologically identified pancreatic tumor
• Locally advanced and/or metastatic pancreatic cancer
• No measurable or evaluable target lesion is required
• No brain metastasis

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• Karnofsky 40%-100%

Hematopoietic:

• WBC at least 3,000/mm^3
• Neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 3 times normal

Renal:

• Creatinine no greater than 1.24 mg/dL OR
• Creatinine clearance at least 80 mL/min

Cardiovascular:

• No overt cardiac disease

Other:

• No peripheral neuropathy
• No uncontrolled infectious or chronic disease
• No second primary except in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No concurrent immunologic therapy

Chemotherapy:

• No prior chemotherapy allowed

Endocrine therapy:

• No concurrent hormonal therapy
• At least 2 weeks since corticoid treatment

Radiotherapy:

• No prior radiotherapy allowed except as an analgesic treatment on metastasis

Surgery:

• Not specified

Belgium
      Hopital de Jolimont, Haine-Saint-Paul,  7100,  Belgium
      Les Cliniques Saint-Joseph ASBL, LIEGE,  B 4000,  Belgium
France
      Centre de Lutte Contre le Cancer, Georges-Francois Leclerc, Dijon,  21079,  France
      Centre Hospital Regional Universitaire de Limoges, Limoges,  87042,  France
      Centre Hospitalier de la Cote Basque, Bayonne,  64109,  France
      Centre Hospitalier de Montlucon, Montlucon,  03109,  France
      Centre Jean Perrin, Clermont-Ferrand,  63011,  France
      Centre Rene Huguenin, Saint Cloud,  92211,  France
      Clinique de l'Orangerie, Strasbourg,  67010,  France
      Clinique Hartmann, Neuilly-sur-Seine,  92200,  France
      Hopital Bellevue, Saint-Etienne,  42055,  France
      Hopital Cochin, Paris,  75674,  France
      Hopital Notre-Dame de Bon Secours, Metz,  55038,  France
      Hopital Paul Brousse, Villejuif,  94804,  France
      Hopital Perpetuel Secours, Levallois-Perret,  92300,  France
      Hopital Saint-Louis, Paris,  75475,  France
Israel
      Wolfson Medical Center, Holon,  58100,  Israel
Italy
      Universita G.D'Annunzio Di Chieti, Chieti,  66100,  Italy
Portugal
      Hospital Fernando Fonseca, Amadora,  P-2700,  Portugal

Study chairs or principal investigators

Francis Levi, MD, PhD,  Hopital Paul Brousse   

Study ID Numbers:  CDR0000065623; EORTC-05962
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003029
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08