Clinical trial NCT00003029: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haine Saint Paul
country: Belgium
facility: Hopital de Jolimont
city: Liege
country: Belgium
facility: Les Cliniques Saint-Joseph ASBL
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
city: Levallois-Perret
country: France
facility: Hopital Perpetuel Secours
city: Limoges
country: France
facility: Centre Hospital Regional Universitaire de Limoges
city: Metz
country: France
facility: Hopital Notre-Dame de Bon Secours
city: Montlucon
country: France
facility: Centre Hospitalier de Montlucon
city: Neuilly sur Seine
country: France
facility: Clinique Hartmann
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hopital Cochin
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: Saint Etienne
country: France
facility: Hopital Bellevue
city: Strasbourg
country: France
facility: Clinique de l'Orangerie
city: Villejuif
country: France
facility: Hopital Paul Brousse
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Chieti
country: Italy
facility: Universita G.D'Annunzio Di Chieti
city: Amadora
country: Portugal
facility: Hospital Fernando Fonseca
Study officials:
affiliation: Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse
name: Francis Levi, MD, PhD
role: STUDY_CHAIR
References: