Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
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 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.|
|Study Start Date:||May 1997|
|Primary Completion Date:||July 2003 (Final data collection date for primary outcome measure)|
- 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.
|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|
|Neuilly sur Seine, France, 92200|
|Paris, France, 75475|
|Paris, France, 75674|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|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|
|Study Chair:||Francis Levi, MD, PhD||Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse|