NCT00003029

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 pancreatic-cancer

Geographic Reach
5 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

6.2 years

First QC Date

November 1, 1999

Last Update Submit

June 29, 2012

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic canceradenocarcinoma of the pancreasstage IV pancreatic cancer

Interventions

cisplatinDRUG
fluorouracilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (19)

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Les Cliniques Saint-Joseph ASBL

Liège, B 4000, Belgium

Location

Centre Hospitalier de la Cote Basque

Bayonne, 64109, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, 21079, France

Location

Hopital Perpetuel Secours

Levallois-Perret, 92300, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 55038, France

Location

Centre Hospitalier de Montlucon

Montluçon, 03109, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Cochin

Paris, 75674, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Hopital Bellevue

Saint-Etienne, 42055, France

Location

Clinique de l'Orangerie

Strasbourg, 67010, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

Wolfson Medical Center

Holon, 58100, Israel

Location

Universita G.D'Annunzio Di Chieti

Chieti, 66100, Italy

Location

Hospital Fernando Fonseca

Amadora, P-2700, Portugal

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

CisplatinFluorouracil

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Francis Levi, MD, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1, 1997

Primary Completion

July 1, 2003

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

FR(14)IT(1)IL(1)BE(2)PT(1)