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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00003029

Collaborator

(none)

200

Enrollment

Locations

10.5

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: cisplatin Drug: fluorouracil	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

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 1, 1997

Actual Primary Completion Date :

Jul 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hopital de Jolimont	Haine Saint Paul	Belgium	7100
2	Les Cliniques Saint-Joseph ASBL	Liege	Belgium	B 4000
3	Centre Hospitalier de la Cote Basque	Bayonne	France	64109
4	Centre Jean Perrin	Clermont-Ferrand	France	63011
5	Centre de Lutte Contre le Cancer, Georges-Francois Leclerc	Dijon	France	21079
6	Hopital Perpetuel Secours	Levallois-Perret	France	92300
7	Centre Hospital Regional Universitaire de Limoges	Limoges	France	87042
8	Hopital Notre-Dame de Bon Secours	Metz	France	55038
9	Centre Hospitalier de Montlucon	Montlucon	France	03109
10	Clinique Hartmann	Neuilly sur Seine	France	92200
11	Hopital Saint-Louis	Paris	France	75475
12	Hopital Cochin	Paris	France	75674
13	Centre Rene Huguenin	Saint Cloud	France	92211
14	Hopital Bellevue	Saint Etienne	France	42055
15	Clinique de l'Orangerie	Strasbourg	France	67010
16	Hopital Paul Brousse	Villejuif	France	94804
17	Wolfson Medical Center	Holon	Israel	58100
18	Universita G.D'Annunzio Di Chieti	Chieti	Italy	66100
19	Hospital Fernando Fonseca	Amadora	Portugal	P-2700