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
Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study
5 other identifiers
interventional
820
1 country
72
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer. PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pancreatic-cancer
Started Feb 2008
Longer than P75 for phase_3 pancreatic-cancer
72 active sites
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
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedDecember 11, 2015
November 1, 2012
5 years
March 12, 2008
December 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
an interim analysis is planned when 196 deaths will be observed
from the date of the first randomization to the date of patient death,due to any cause, or to the last date the patient was known to be alive, assessed up to 8 years after the beginning of the study
Secondary Outcomes (3)
Progression-free survival
time from the date of the first randomization to the date of progressive disease or death, assessed up to 8 years after the beginning of the study.
Relationship between biological markers and survival
From baseline to death, assessed up to 8 years after the beginning of the study
tolerance to erlotinib
from start of treatment until the event has resolved or stabilized or until death
Study Arms (4)
Arm 1 (A1) - Gemcitabine
ACTIVE COMPARATORGemcitabine 2 months, then stop until progression
Arm 2 (B1) Gemcitabine + Erlotinib
EXPERIMENTALB1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
Arm 3 (A2) CRT
EXPERIMENTALA2 CRT then stop until progression
Arm 4 (B2) CRT then erlotinib
EXPERIMENTALB2 CRT then erlotinib maintenance (150mg/d) until progression
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Centre Radiotherapie Oncologie Moyenne Garonne
Agen, 47000, France
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, 13616, France
Centre Paul Papin
Angers, 49036, France
Polyclinique Sainte Marguerite
Auxerre, 89000, France
Centre Hospitalier d'Auxerre
Auxerre, 89011, France
Institut Sainte Catherine
Avignon, 84000, France
Hopital Duffaut
Avignon, 84902, France
Centre Hospitalier de la Cote Basque
Bayonne, 64100, France
Centre Hospitalier de Beauvais
Beauvais, 72037, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, 25030, France
Hopital de Beziers
Béziers, 34525, France
Hopital Saint Andre
Bordeaux, 33075, France
Institut Bergonie
Bordeaux, 33076, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
Clinique Tivoli
Bordeaux, F-33000, France
Hopital Ambroise Pare
Boulogne-Billancourt, F-92104, France
Centre Hospitalier Pierre Oudot
Bourgoin, 38300, France
CHU de Caen
Caen, 14033, France
Polyclinique Du Parc
Caen, 14052, France
Hopital Beaujon
Clichy, 92110, France
Hopital Louis Pasteur
Colmar, 68024, France
Centre Hospitalier Compiegne
Compiègne, 60321, France
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94000, France
Centre Hospitalier de Dax
Dax, 40100, France
Centre Hospitalier de Digne les Bains
Digne-les-Bains, 04003, France
Hopital Du Bocage
Dijon, 21034, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, 21079, France
Centre Hospitalier Draguignan
Draguignan, 83300, France
CHU de Grenoble - Hopital de la Tronche
Grenoble, 38043, France
Centre Hospitalier Departemental
La Roche-sur-Yon, F-85025, France
Centre Hospitalier de Lagny
Lagny-sur-Marne, 77405, France
Hopital Louis Pasteur - Le Coudray
Le Coudray, 28630, France
Centre Hospitalier Universitaire de Bicetre
Le Kremlin-Bicêtre, 94275, France
Clinique Victor Hugo
Le Mans, F-72000, France
Hopital Robert Boulin
Libourne, 33500, France
Polyclinique Du Bois
Lille, 59000, France
Polyclinique des Quatre Pavillons
Lormont, 33310, France
Centre Hospitalier St. Joseph St. Luc
Lyon, 69007, France
Hopital Prive Jean Mermoz
Lyon, 69008, France
Hopital de la Croix Rousse
Lyon, 69317, France
Centre Leon Berard
Lyon, 69373, France
Hopital Edouard Herriot - Lyon
Lyon, 69437, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273, France
CHU de la Timone
Marseille, 13385, France
Centre Gray
Maubeuge, 59600, France
Centre Hospitalier Chanaux
Mâcon, 71018, France
Centre Hospitalier de Meaux
Meaux, 77104, France
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, 40000, France
Centre Hospitalier de Montelimar
Montélimar, 26200, France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
Nîmes, 30029, France
Clinique De Valdegour
Nîmes, 30900, France
CHR D'Orleans - Hopital de la Source
Orléans, 45067, France
Hopital Pitie-Salpetriere
Paris, 75013, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Hopital Bichat - Claude Bernard
Paris, 75018, France
Hopital Saint-Louis
Paris, 75475, France
Hopital Saint Antoine
Paris, 75571, France
Hopital Saint Joseph
Paris, 75674, France
Hopital Tenon
Paris, 75970, France
Centre Catalan d'Oncologie
Perpignan, 66000, France
Hopital Haut Leveque
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU Poitiers
Poitiers, 86021, France
Hopital Rene Dubos
Pontoise, 95300, France
CHU - Robert Debre
Reims, 51092, France
Hopital Charles Nicolle
Rouen, 76031, France
Centre Hospitalier
Saint-Omer, 62505, France
Centre Hospitalier de Tarbes
Tarbes, 65013, France
Centre Hospitalier Regional Metz Thionville
Thionville, 57126, France
CHRU de Tours - Hopital Trousseau
Tours, 37000, France
Nouvelle Clinique Generale
Valence, 26000, France
Centre Hospitalier Bretagne Atlantique
Vannes, 56016, France
Related Publications (1)
Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.
PMID: 27139057DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pascal Hammel, MD, PhD
Hopital Beaujon
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2008
First Posted
March 13, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2013
Study Completion
September 1, 2014
Last Updated
December 11, 2015
Record last verified: 2012-11