Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage III pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas meeting the following criteria:
- De novo locally advanced disease
- Unresectable disease
Stage III according to the UICC classification
- No distant metastases
- No localized stage IA-IIB or metastatic stage IV disease according to UICC classification
- Not considered for curative resection after pluridisciplinary discussion
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Polynuclear neutrophils ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 g/dL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- For patients who have had a recent biliary drain and whose bilirubin is descending, a value of ≤ 3 times ULN is acceptable
- Creatinine ≤ 2 mg/dL
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Albumin ≥ 25 g/L
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of therapy
Exclusion criteria:
- Diarrhea ≥ grade 2 and/or uncontrolled diarrhea
- Affiliated with a social security regime
- Unable to follow instructions for psychological, familial, or geographical reasons
- Allergic to one of the ingredients in erlotinib hydrochloride
- Cancer within the past 5 years, except for in situ cancer of the neck of the uterus or basal cell skin cancer
- Severe infection
- Ophthalmic disease (i.e., inflammation, keratopathy, or infection)
- Symptomatic coronary or cardiac insufficiency, myocardial infarction, or stroke within the last 6 months
- Unable to take oral treatments
- Gastrointestinal disorders that could be associated with absorption disorders
- Untreated gastric or duodenal ulcer
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy (including abdominal radiotherapy) or chemotherapy for any reason
- No prior anti-epidermal growth factor-receptor therapy
Sites / Locations
- Centre Radiotherapie Oncologie Moyenne Garonne
- Centre Hospitalier d'Aix en Provence
- Centre Paul Papin
- Polyclinique Sainte Marguerite
- Centre Hospitalier d'Auxerre
- Institut Sainte Catherine
- Hopital Duffaut
- Centre Hospitalier de la Cote Basque
- Centre Hospitalier de Beauvais
- Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
- Hopital de Beziers
- Hopital Saint Andre
- Institut Bergonie
- Polyclinique Bordeaux Nord Aquitaine
- Clinique Tivoli
- Hopital Ambroise Pare
- Centre Hospitalier Pierre Oudot
- CHU de Caen
- Polyclinique Du Parc
- Hopital Beaujon
- Hopital Louis Pasteur
- Centre Hospitalier Compiegne
- Centre Hospitalier Universitaire Henri Mondor
- Centre Hospitalier de Dax
- Centre Hospitalier de Digne les Bains
- Hopital Du Bocage
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
- Centre Hospitalier Draguignan
- CHU de Grenoble - Hopital de la Tronche
- Centre Hospitalier Departemental
- Centre Hospitalier de Lagny
- Hopital Louis Pasteur - Le Coudray
- Centre Hospitalier Universitaire de Bicetre
- Clinique Victor Hugo
- Hopital Robert Boulin
- Polyclinique Du Bois
- Polyclinique des Quatre Pavillons
- Centre Hospitalier St. Joseph St. Luc
- Hopital Prive Jean Mermoz
- Hopital de la Croix Rousse
- Centre Leon Berard
- Hopital Edouard Herriot - Lyon
- Centre Hospitalier Chanaux
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
- CHU de la Timone
- Centre Gray
- Centre Hospitalier de Meaux
- Centre Hospitalier General de Mont de Marsan
- Centre Hospitalier de Montelimar
- C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
- Clinique De Valdegour
- CHR D'Orleans - Hopital de la Source
- Hopital Pitie-Salpetriere
- Hopital Europeen Georges Pompidou
- Hopital Bichat - Claude Bernard
- Hopital Saint-Louis
- Hopital Saint Antoine
- Hopital Saint Joseph
- Hopital Tenon
- Centre Catalan d'Oncologie
- Hopital Haut Leveque
- Centre Hospitalier Lyon Sud
- CHU Poitiers
- Hopital Rene Dubos
- CHU - Robert Debre
- Hopital Charles Nicolle
- Centre Hospitalier
- Centre Hospitalier de Tarbes
- Centre Hospitalier Regional Metz Thionville
- CHRU de Tours - Hopital Trousseau
- Nouvelle Clinique Generale
- Centre Hospitalier Bretagne Atlantique
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Arm 1 (A1) - Gemcitabine
Arm 2 (B1) Gemcitabine + Erlotinib
Arm 3 (A2) CRT
Arm 4 (B2) CRT then erlotinib
Gemcitabine 2 months, then stop until progression
B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
A2 CRT then stop until progression
B2 CRT then erlotinib maintenance (150mg/d) until progression