Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: cisplatin (Drug); fluorouracil (Drug); chemotherapy (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: European Organization for Research and Treatment of Cancer Official(s) and/or principal investigator(s):
Francis Levi, MD, PhD, Affiliation: Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse
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.
Clinical Details
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 design: Treatment, Randomized, Active Control
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hopital de Jolimont, Haine Saint Paul 7100, Belgium
Les Cliniques Saint-Joseph ASBL, Liege B 4000, Belgium
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc, Dijon 21079, France
Centre Hospital Regional Universitaire de Limoges, Limoges 87042, France
Centre Hospitalier de la Cote Basque, Bayonne 64109, France
Centre Hospitalier de Montlucon, Montlucon 03109, France
Centre Jean Perrin, Clermont-Ferrand 63011, France
Centre Rene Huguenin, Saint Cloud 92211, France
Clinique de l'Orangerie, Strasbourg 67010, France
Clinique Hartmann, Neuilly sur Seine 92200, France
Hopital Bellevue, Saint Etienne 42055, France
Hopital Cochin, Paris 75674, France
Hopital Notre-Dame de Bon Secours, Metz 55038, France
Hopital Paul Brousse, Villejuif 94804, France
Hopital Perpetuel Secours, Levallois-Perret 92300, France
Hopital Saint-Louis, Paris 75475, France
Wolfson Medical Center, Holon 58100, Israel
Universita G.D'Annunzio Di Chieti, Chieti 66100, Italy
Hospital Fernando Fonseca, Amadora P-2700, Portugal
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 1997
Last updated: November 16, 2007
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