Clinical trial NCT00303758: Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: Federation Francophone de Cancerologie Digestive
Sponsor class: OTHER
First posted: 2006-03-17
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Overall survival
timeFrame: 2012
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2012
measure: Toxicity
timeFrame: 2012
measure: Quality of life
timeFrame: 2012
measure: Percentage of patients needing second-line therapy
timeFrame: 2012
measure: Duration of hospitalization
timeFrame: 2012
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Centre Hospitalier d'Abbeville
city: Avignon
country: France
facility: Hopital Duffaut
city: Blois
country: France
facility: Centre Hospitalier de Blois
city: Boulogne Sur Mer
country: France
facility: Centre Hospitalier Docteur Duchenne
city: Boulogne
country: France
facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne
city: Bourg En Bresse
country: France
facility: C.H. Bourg En Bresse
city: Bourgoin-Jallieu
country: France
facility: Centre Hospitalier Pierre Oudot
city: Caen
country: France
facility: Centre Hospitalier Universitaire d'Amiens
city: Chalons-en-Champagne
country: France
facility: Centre Hospitalier de Chalons-en-Champagne
city: Clermont-Ferrand
country: France
facility: CHR Clermont Ferrand, Hotel dieu
city: Clichy
country: France
facility: Hopital Beaujon
city: Colmar
country: France
facility: Hopital Louis Pasteur
city: Dijon
country: France
facility: Hopital Du Bocage
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc
city: Draguignan
country: France
facility: Centre Hospitalier Draguignan
city: Dunkerque
country: France
facility: Centre Hospitalier De Dunkerque - CHD
city: Elbeuf
country: France
facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf
city: Grenoble
country: France
facility: CHU de Grenoble - Hopital de la Tronche
city: Guilherand Granges
country: France
facility: Clinique Pasteur
city: Libourne
country: France
facility: Hopital Robert Boulin
city: Lille
country: France
facility: Centre Hospital Universitaire Hop Huriez
city: Lille
country: France
facility: Centre Hospitalier Regional et Universitaire de Lille
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Marseille
country: France
facility: CHU de la Timone
city: Marseille
country: France
facility: CHU Nord
city: Martigues
country: France
facility: Centre Hospitalier de Martigues
city: Mont-de-Marsan
country: France
facility: Centre Hospitalier General de Mont de Marsan
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Nantes
country: France
facility: CHR Hotel Dieu
city: Orleans
country: France
facility: CHR D'Orleans - Hopital de la Source
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Bichat - Claude Bernard
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Pontoise
country: France
facility: Clinique Ste - Marie
city: Reims
country: France
facility: CHU - Robert Debre
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Saint Brieuc
country: France
facility: Clinique Armoricaine De Radiologie
city: Saint Martin Boulogne
country: France
facility: Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault
city: Saint-Quentin
country: France
facility: Centre Hospitalier de Saint-Quentin
city: Semur en Auxois
country: France
facility: Centre Hospitalier de Semur en Auxois
city: Soissons cedex
country: France
facility: Centre Hospitalier de Soissons
city: Strasbourg
country: France
facility: Hopital Universitaire Hautepierre
city: Tarbes
country: France
facility: Centre Hospitalier de Tarbes
city: Valence
country: France
facility: Nouvelle Clinique Generale
Study officials:
affiliation: CHU de la Timone
name: Jean-Francois Seitz, MD
role: STUDY_CHAIR
affiliation: Hopital Haut Leveque
name: Jean-Louis Legoux, MD
role: STUDY_CHAIR
affiliation: Hopital Beaujon
name: Pascal Hammel, MD, PhD
role: STUDY_CHAIR
References:
citation: Dahan L, Bonnetain F, Ychou M, Mitry E, Gasmi M, Raoul JL, Cattan S, Phelip JM, Hammel P, Chauffert B, Michel P, Legoux JL, Rougier P, Bedenne L, Seitz JF; Federation Francophone de Cancerologie Digestive. Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301). Gut. 2010 Nov;59(11):1527-34. doi: 10.1136/gut.2010.216135.