Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

March 3, 2014 updated by: Federation Francophone de Cancerologie Digestive

Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.

Secondary

  • Compare progression-free survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the percentage of these patients needing second-line therapy.
  • Compare the duration of hospitalization of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm I.

Quality of life is assessed at baseline and then every 2 months.

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • France
      • Abbeville, France, 80101
        • Centre Hospitalier d'Abbeville
      • Avignon, France, 84902
        • Hopital Duffaut
      • Blois, France, 41016
        • Centre Hospitalier de Blois
      • Boulogne, France, F-92104
        • Centre Hospitalier Universitaire Ambroise Pare - Boulogne
      • Boulogne Sur Mer, France, 62200
        • Centre Hospitalier Docteur Duchenne
      • Bourg En Bresse, France, 01012
        • C.H. Bourg En Bresse
      • Bourgoin-Jallieu, France, 38300
        • Centre hospitalier Pierre Oudot
      • Caen, France, 14076
        • Centre Hospitalier Universitaire D'Amiens
      • Chalons-en-Champagne, France, 51000
        • Centre Hospitalier de Chalons-en-Champagne
      • Clermont-Ferrand, France, 63003
        • CHR Clermont Ferrand, Hotel Dieu
      • Clichy, France, 92118
        • Hopital Beaujon
      • Colmar, France, 68024
        • Hôpital Louis Pasteur
      • Dijon, France, 21034
        • Hôpital du Bocage
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • Draguignan, France, 83300
        • Centre Hospitalier Draguignan
      • Dunkerque, France, 59240
        • Centre Hospitalier De Dunkerque - CHD
      • Elbeuf, France, 76503
        • Centre Hospitalier Intercommunal St. Aubin les Elbeuf
      • Grenoble, France, 38043
        • CHU de Grenoble - Hopital de la Tronche
      • Guilherand Granges, France, 07500
        • Clinique Pasteur
      • Libourne, France, 33500
        • Hôpital Robert Boulin
      • Lille, France, 59037
        • Centre Hospital Universitaire Hop Huriez
      • Lille, France, 59037
        • Centre Hospitalier Regional et Universitaire de Lille
      • Lyon, France, 69437
        • Hôpital Édouard Herriot
      • Marseille, France, 13385
        • CHU de la Timone
      • Marseille, France, 13915
        • CHU Nord
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Martigues, France, 13698
        • Centre Hospitalier de Martigues
      • Mont-de-Marsan, France, 40000
        • Centre Hospitalier General de Mont de Marsan
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Nantes, France, 44093
        • CHR Hotel Dieu
      • Orleans, France, 45100
        • CHR D'Orleans - Hopital de la Source
      • Paris, France, 75015
        • Hôpital Europeen Georges Pompidou
      • Paris, France, 75018
        • Hopital Bichat - Claude Bernard
      • Pessac, France, 33604
        • Hopital Haut Lévêque
      • Pontoise, France, 95301
        • Clinique Ste - Marie
      • Reims, France, 51092
        • CHU - Robert Debre
      • Rennes, France, 35064
        • Centre Eugene Marquis
      • Rouen, France, 76031
        • Hôpital Charles Nicolle
      • Saint Brieuc, France, F-22015
        • Clinique Armoricaine de Radiologie
      • Saint Martin Boulogne, France, 62280
        • Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault
      • Saint-Quentin, France, 02321
        • Centre Hospitalier de Saint-Quentin
      • Semur en Auxois, France, 21140
        • Centre Hospitalier de Semur en Auxois
      • Soissons cedex, France, 02209
        • Centre Hospitalier de Soissons
      • Strasbourg, France, 67098
        • Hopital Universitaire Hautepierre
      • Tarbes, France, 65013
        • Centre hospitalier de Tarbes
      • Valence, France, 26000
        • Nouvelle Clinique Generale

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampulla

    • Metastatic disease
    • Unresectable disease

  • Measurable disease, meeting the following criteria:

    • No prior radiotherapy to the only site of measurable disease
    • Diameter > 10 mm by spiral CT scan or MRI OR > 20 mm by conventional methods
  • No brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 2 months
  • No contraindication to chemotherapy
  • Creatinine clearance > 60 mL/min
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Alkaline phosphatase < 5 times normal
  • Bilirubin ≤ 3 mg/dL
  • No coronary insufficiency
  • No symptomatic cardiac disease
  • Good hydration possible
  • No Child-Pugh class B or C cirrhosis
  • No other malignancy except for basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior palliative or adjuvant chemotherapy
  • At least 4 weeks since prior radiotherapy
  • No radiotherapy during or for 4 weeks after study therapy
  • No other concurrent anticancer therapy

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LV5FU2 simplifié + cisplatine puis gemcitabine si progression
Drug: fluorouracil
Drug: leucovorin calcium
Drug: cisplatin
Drug: gemcitabine hydrochloride
Experimental: gemcitabine puis LV5FU2 simplifié + cisplatine si progression
Drug: fluorouracil
Drug: leucovorin calcium
Drug: cisplatin
Drug: gemcitabine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2012
2012

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: 2012
2012
Progression-free survival
Time Frame: 2012
2012
Quality of life
Time Frame: 2012
2012
Percentage of patients needing second-line therapy
Time Frame: 2012
2012
Duration of hospitalization
Time Frame: 2012
2012

Collaborators and Investigators

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

Sponsor

Federation Francophone de Cancerologie Digestive

Investigators

  • Study Chair: Jean-Francois Seitz, MD, CHU de la Timone
  • Study Chair: Jean-Louis Legoux, MD, Hopital Haut Lévêque
  • Study Chair: Pascal Hammel, MD, PhD, Hopital Beaujon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 15, 2006

First Submitted That Met QC Criteria

March 15, 2006

First Posted (Estimate)

March 17, 2006

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000453841
  • FFCD-0301
  • EU-20543

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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