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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: fluorouracil; Drug: cisplatin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Investigators: Study Chair: Francis Levi, MD, PhD, Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse

Study record dates

Study Major Dates

• Study Start: May 1, 1997
• Primary Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): July 2, 2012
• Last Update Submitted That Met QC Criteria: June 29, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: adenocarcinoma of the pancreas; stage IV pancreatic cancer; stage III pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fluorouracil
• Other Study ID Numbers: EORTC-05962