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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cisplatin
fluorouracil
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital de Jolimont
  • Les Cliniques Saint-Joseph ASBL
  • Centre Hospitalier de la Cote Basque
  • Centre Jean Perrin
  • Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
  • Hopital Perpetuel Secours
  • Centre Hospital Regional Universitaire de Limoges
  • Hopital Notre-Dame de Bon Secours
  • Centre Hospitalier de Montlucon
  • Clinique Hartmann
  • Hopital Saint-Louis
  • Hopital Cochin
  • Centre Rene Huguenin
  • Hopital Bellevue
  • Clinique de l'Orangerie
  • Hopital Paul Brousse
  • Wolfson Medical Center
  • Universita G.D'Annunzio Di Chieti
  • Hospital Fernando Fonseca

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 29, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00003029
Brief Title
Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Levi, MD, PhD
Organizational Affiliation
Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital de Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Les Cliniques Saint-Joseph ASBL
City
Liege
ZIP/Postal Code
B 4000
Country
Belgium
Facility Name
Centre Hospitalier de la Cote Basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Perpetuel Secours
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
55038
Country
France
Facility Name
Centre Hospitalier de Montlucon
City
Montlucon
ZIP/Postal Code
03109
Country
France
Facility Name
Clinique Hartmann
City
Neuilly sur Seine
ZIP/Postal Code
92200
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
Hopital Bellevue
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Clinique de l'Orangerie
City
Strasbourg
ZIP/Postal Code
67010
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Universita G.D'Annunzio Di Chieti
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Hospital Fernando Fonseca
City
Amadora
ZIP/Postal Code
P-2700
Country
Portugal

12. IPD Sharing Statement

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

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