Fluorouracil With Or Without Cisplatin In Treating Patients With Advanced Or Metastatic Cancer Of The Pancreas

Study Overview

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.

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.

Pancreatic Cancer

DRUG: cisplatin
DRUG: fluorouracil

EORTC-05962

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 1999-11-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-06-29
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-07-02
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2012-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

Karnofsky 40%-100%

WBC at least 3,000/mm^3
Neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Bilirubin no greater than 3 times normal

Creatinine no greater than 1.24 mg/dL OR
Creatinine clearance at least 80 mL/min

No overt cardiac disease

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

No concurrent immunologic therapy

No prior chemotherapy allowed

No concurrent hormonal therapy
At least 2 weeks since corticoid treatment

No prior radiotherapy allowed except as an analgesic treatment on metastasis

Not specified

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Francis Levi, MD, PhD, Institut de Cancerologie et D'Immunogenetique at Hopital Paul-Brousse

Publications

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General Publications

No publications available

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Clinical Trial Record