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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier:
NCT00303758
First received: March 15, 2006
Last updated: March 3, 2014
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Drug: leucovorin calcium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Federation Francophone de Cancerologie Digestive:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 2012 ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 2012 ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 2012 ] [ Designated as safety issue: No ]
  • Percentage of patients needing second-line therapy [ Time Frame: 2012 ] [ Designated as safety issue: No ]
  • Duration of hospitalization [ Time Frame: 2012 ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: October 2005
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LV5FU2 simplifié + cisplatine puis gemcitabine si progression
LV5FU2 simplifié + cisplatine puis gemcitabine si progression
Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium
Experimental: gemcitabine puis LV5FU2 simplifié + cisplatine si progression
gemcitabine puis LV5FU2 simplifié + cisplatine si progression
Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303758

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

Additional Information:
Publications:
Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT00303758     History of Changes
Other Study ID Numbers: CDR0000453841, FFCD-0301, EU-20543
Study First Received: March 15, 2006
Last Updated: March 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Federation Francophone de Cancerologie Digestive:
adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Fluorouracil
Levoleucovorin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014