Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003029
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: cisplatin Drug: fluorouracil Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Infusional 5-Fluorouracil With or Without Cisplatin and With or Without Chronomodulation Against Locally-Advanced or Metastatic Pancreatic Cancer. A Multicenter Randomized Phase III Trial.
Study Start Date : May 1997
Actual Primary Completion Date : July 2003

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 40%-100%


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


  • Bilirubin no greater than 3 times normal


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


  • No overt cardiac disease


  • 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


Biologic therapy:

  • No concurrent immunologic therapy


  • No prior chemotherapy allowed

Endocrine therapy:

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


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


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003029

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

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00003029     History of Changes
Other Study ID Numbers: EORTC-05962
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs