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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003029
First received: November 1, 1999
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: cisplatin
Drug: fluorouracil
Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 200
Study Start Date: May 1997
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003029

Locations
Belgium
Hopital de Jolimont
Haine Saint Paul, Belgium, 7100
Les Cliniques Saint-Joseph ASBL
Liege, Belgium, B 4000
France
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
Israel
Wolfson Medical Center
Holon, Israel, 58100
Italy
Universita G.D'Annunzio Di Chieti
Chieti, Italy, 66100
Portugal
Hospital Fernando Fonseca
Amadora, Portugal, P-2700
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003029     History of Changes
Other Study ID Numbers: EORTC-05962, EORTC-05962
Study First Received: November 1, 1999
Last Updated: June 29, 2012
Health Authority: United States: Federal Government

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
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014