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

Phase 3

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT00003029
• Lead Sponsor: 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.

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 Timeline

• Study Start: 1997-05
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (19)

Centre Hospitalier de la Cote Basque; 🇫🇷 Bayonne, France

Hopital Perpetuel Secours; 🇫🇷 Levallois-Perret, France

Les Cliniques Saint-Joseph ASBL; 🇧🇪 Liege, Belgium

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc; 🇫🇷 Dijon, France

Centre Hospital Regional Universitaire de Limoges; 🇫🇷 Limoges, France

Hopital Notre-Dame de Bon Secours; 🇫🇷 Metz, France

Clinique Hartmann; 🇫🇷 Neuilly sur Seine, France

Centre Hospitalier de Montlucon; 🇫🇷 Montlucon, France

Hopital Saint-Louis; 🇫🇷 Paris, France

Hopital Bellevue; 🇫🇷 Saint Etienne, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Hopital Cochin; 🇫🇷 Paris, France

Clinique de l'Orangerie; 🇫🇷 Strasbourg, France

Wolfson Medical Center; 🇮🇱 Holon, Israel

Hospital Fernando Fonseca; 🇵🇹 Amadora, Portugal

Hopital Paul Brousse; 🇫🇷 Villejuif, France

Universita G.D'Annunzio Di Chieti; 🇮🇹 Chieti, Italy

Hopital de Jolimont; 🇧🇪 Haine Saint Paul, Belgium