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

NCT ID: NCT00003029

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-05-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis Levi, MD, PhD

Role: STUDY_CHAIR

Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse

Locations

Hopital de Jolimont

Haine-Saint-Paul, , Belgium

Les Cliniques Saint-Joseph ASBL

Liège, , Belgium

Centre Hospitalier de la Cote Basque

Bayonne, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, , France

Hopital Perpetuel Secours

Levallois-Perret, , France

Centre Hospital Regional Universitaire de Limoges

Limoges, , France

Hopital Notre-Dame de Bon Secours

Metz, , France

Centre Hospitalier de Montlucon

Montluçon, , France

Clinique Hartmann

Neuilly-sur-Seine, , France

Hopital Saint-Louis

Paris, , France

Hopital Cochin

Paris, , France

Centre Rene Huguenin

Saint-Cloud, , France

Hopital Bellevue

Saint-Etienne, , France

Clinique de l'Orangerie

Strasbourg, , France

Hopital Paul Brousse

Villejuif, , France

Wolfson Medical Center

Holon, , Israel

Universita G.D'Annunzio Di Chieti

Chieti, , Italy

Hospital Fernando Fonseca

Amadora, , Portugal

Countries

Belgium; France; Israel; Italy; Portugal

Other Identifiers

EORTC-05962

Identifier Type: -

Identifier Source: secondary_id

EORTC-05962

Identifier Type: -

Identifier Source: org_study_id