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
NCT ID: NCT00634725
Last Updated: 2015-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
820 participants
INTERVENTIONAL
2008-02-29
2014-09-30
Brief Summary
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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.
Detailed Description
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Primary
* To assess whether administrating chemoradiotherapy in patients whose tumor is controlled after 4 months of induction chemotherapy (CT) increases survival compared with continuation of the same CT in patients with unresectable, locally advanced adenocarcinoma of the pancreas.
Secondary
* To assess whether erlotinib hydrochloride combined with gemcitabine hydrochloride and administered as maintenance treatment increases progression-free survival compared with gemcitabine hydrochloride alone and without maintenance treatment.
* To evaluate the response rate in the CT and chemoradiotherapy (CRT) arms.
* To evaluate tolerance to erlotinib hydrochloride as maintenance treatment after the end of CT or CRT.
* To study the predictive molecular factors (i.e., survivin, K-ras, EGFR, PTEN, or AKT) of survival.
OUTLINE: This is a multicenter study. Patients in the first randomization are stratified according to center and ECOG performance status (0-1 vs 2). Patients in the second randomization are stratified according to center and initial treatment arm (I vs II).
* First randomization: Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. Following the first evaluation, patients continue to receive gemcitabine hydrochloride on days 57, 64, 71, 85, 92, and 99 for a total of 4 months.
* Arm II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. Following the first evaluation, patients continue to receive gemcitabine hydrochloride on days 57, 64, 71, 85, 92, and 99. Patients also receive oral erlotinib hydrochloride once daily for 4 months.
After completion of treatment in the first randomization proceed to the second randomization.
* Second randomization: Patients are randomized to 1 of 4 treatment arms.
* Arm I: Patients continue gemcitabine hydrochloride as in arm I in the first randomization on days 113, 120, and 127 and on days 141, 148, and 155 for 2 months in the absence of disease progression.
* Arm II: Patients continue gemcitabine hydrochloride as in arm II in the first randomization on days 113, 120, and 127 and on days 141, 148, and 155 and oral erlotinib hydrochloride daily for 2 months followed by erlotinib hydrochloride alone as maintenance therapy in the absence of disease progression.
* Arm III: Patients receive oral capecitabine twice daily and undergo radiotherapy beginning on day 127, 5 days a week, for 6 weeks, in the absence of disease progression.
* Arm IV: Patients receive oral capecitabine twice daily and undergo radiotherapy beginning on day 127, 5 days a week, for 6 weeks. Beginning 15 days after completion of CRT, patients receive a reintroduction of oral erlotinib hydrochloride alone once daily in the absence of disease progression or unacceptable toxicity.
Tumor tissue will be analyzed for the relationship between biological markers and resistance to treatment.
After completion of study treatment, patients are followed every 2 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 (A1) - Gemcitabine
Gemcitabine 2 months, then stop until progression
gemcitabine hydrochloride
laboratory biomarker analysis
Arm 2 (B1) Gemcitabine + Erlotinib
B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
erlotinib hydrochloride
gemcitabine hydrochloride
laboratory biomarker analysis
Arm 3 (A2) CRT
A2 CRT then stop until progression
capecitabine
laboratory biomarker analysis
radiation therapy
Arm 4 (B2) CRT then erlotinib
B2 CRT then erlotinib maintenance (150mg/d) until progression
capecitabine
erlotinib hydrochloride
laboratory biomarker analysis
radiation therapy
Interventions
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capecitabine
erlotinib hydrochloride
gemcitabine hydrochloride
laboratory biomarker analysis
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
120 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Responsible Party
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Principal Investigators
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Pascal Hammel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hopital Beaujon
Locations
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Centre Radiotherapie Oncologie Moyenne Garonne
Agen, , France
Centre Hospitalier d'Aix en Provence
Aix-en-Provence, , France
Centre Paul Papin
Angers, , France
Polyclinique Sainte Marguerite
Auxerre, , France
Centre Hospitalier d'Auxerre
Auxerre, , France
Institut Sainte Catherine
Avignon, , France
Hopital Duffaut
Avignon, , France
Centre Hospitalier de la Cote Basque
Bayonne, , France
Centre Hospitalier de Beauvais
Beauvais, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Hopital de Beziers
Béziers, , France
Hopital Saint Andre
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Clinique Tivoli
Bordeaux, , France
Hopital Ambroise Pare
Boulogne-Billancourt, , France
Centre Hospitalier Pierre Oudot
Bourgoin, , France
CHU de Caen
Caen, , France
Polyclinique Du Parc
Caen, , France
Hopital Beaujon
Clichy, , France
Hopital Louis Pasteur
Colmar, , France
Centre Hospitalier Compiegne
Compiègne, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Centre Hospitalier de Dax
Dax, , France
Centre Hospitalier de Digne les Bains
Digne-les-Bains, , France
Hopital Du Bocage
Dijon, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Centre Hospitalier Draguignan
Draguignan, , France
CHU de Grenoble - Hopital de la Tronche
Grenoble, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Centre Hospitalier de Lagny
Lagny-sur-Marne, , France
Hopital Louis Pasteur - Le Coudray
Le Coudray, , France
Centre Hospitalier Universitaire de Bicetre
Le Kremlin-Bicêtre, , France
Clinique Victor Hugo
Le Mans, , France
Hopital Robert Boulin
Libourne, , France
Polyclinique Du Bois
Lille, , France
Polyclinique des Quatre Pavillons
Lormont, , France
Centre Hospitalier St. Joseph St. Luc
Lyon, , France
Hopital Prive Jean Mermoz
Lyon, , France
Hopital de la Croix Rousse
Lyon, , France
Centre Leon Berard
Lyon, , France
Hopital Edouard Herriot - Lyon
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
CHU de la Timone
Marseille, , France
Centre Gray
Maubeuge, , France
Centre Hospitalier Chanaux
Mâcon, , France
Centre Hospitalier de Meaux
Meaux, , France
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, , France
Centre Hospitalier de Montelimar
Montélimar, , France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
Nîmes, , France
Clinique De Valdegour
Nîmes, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Hopital Pitie-Salpetriere
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Bichat - Claude Bernard
Paris, , France
Hopital Saint-Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital Saint Joseph
Paris, , France
Hopital Tenon
Paris, , France
Centre Catalan d'Oncologie
Perpignan, , France
Hopital Haut Leveque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Poitiers
Poitiers, , France
Hopital Rene Dubos
Pontoise, , France
CHU - Robert Debre
Reims, , France
Hopital Charles Nicolle
Rouen, , France
Centre Hospitalier
Saint-Omer, , France
Centre Hospitalier de Tarbes
Tarbes, , France
Centre Hospitalier Regional Metz Thionville
Thionville, , France
CHRU de Tours - Hopital Trousseau
Tours, , France
Nouvelle Clinique Generale
Valence, , France
Centre Hospitalier Bretagne Atlantique
Vannes, , France
Countries
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References
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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.
Other Identifiers
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GERCOR-LAP-07-D07-1
Identifier Type: -
Identifier Source: secondary_id
EU=20827
Identifier Type: -
Identifier Source: secondary_id
ROCHE-GERCOR-LAP-07-D07-1
Identifier Type: -
Identifier Source: secondary_id
EudraCT- 2007-001174-81
Identifier Type: -
Identifier Source: secondary_id
CDR0000589283
Identifier Type: -
Identifier Source: org_study_id