Tarceva Italian Lung Optimization tRial (TAILOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637910
Recruitment Status : Unknown
Verified February 2012 by Scanni Alberto, Fatebenefratelli and Ophthalmic Hospital.
Recruitment status was:  Recruiting
First Posted : March 18, 2008
Last Update Posted : February 24, 2012
Mario Negri Institute for Pharmacological Research
Niguarda Hospital
Information provided by (Responsible Party):
Scanni Alberto, Fatebenefratelli and Ophthalmic Hospital

Brief Summary:
The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in second line in wild-type EGFR tumour patients.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer (NSCLC) Drug: Erlotinib Drug: Docetaxel Phase 3

Detailed Description:

Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines with a small benefit on Overall Survival. Recent evidence suggest that patients with EGFR mutations have a clear benefit when they are treated with EGFR tyrosine kinase inhibitors, while the role of these drugs in wild-type EGFR patients, that are representing the large majority (about 85-90%), is still unclear and no properly planned trials assessed before this issue. Recently, indirect evidence on subgroup analyses on randomized trial suggest that chemotherapy might be superior to erlotinib in wild-type EGFR patients.

Moreover, several authors do not recommend the use of EGFR determined with immunohistochemistry (IHC) or FISH because they do not reproducibly predict outcome.

For these reasons the protocol was amended in May 2011 in a superiority trial of docetaxel versus erlotinib, while the first version was aimed to assess the interaction with biomarkers.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial
Study Start Date : November 2007
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Erlotinib Arm Drug: Erlotinib
Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops
Other Name: Tarceva
Active Comparator: Docetaxel Arm Drug: Docetaxel
Docetaxel 75 mg/mq on day 1, every 21 days (3-weekly schedule) or Docetaxel 35 mg/mq 0n day 1,8 and 15 every 28 days (weekly schedule). _Until disease progression or unacceptable toxicity develops
Other Name: Taxotere

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 12 months after the last patient is randomized ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: with 4 years and 12 months after the last patient is randomized ]
  2. Response assessed with RECIST criteria [ Time Frame: within 4 years ]
  3. Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires [ Time Frame: within 4 years ]
  4. Toxicity, graded according to the NCI-CTAE version 3.0 [ Time Frame: within 4 years ]
  5. Frequency and nature of serious adverse reactions [ Time Frame: within 4 years ]
  6. Premature withdrawals [ Time Frame: within 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older
  • Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study
  • Absence of EGFR mutations of exons 19 or 21 (randomization)
  • Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
  • One prior platinum-based at adequate doses and taxane free regimen
  • Measurable (uni-dimensional) disease by RECIST in a lesion not previously irradiated or non-measurable disease
  • ECOG-PS 0-2
  • ANC greater than 1.5 x 109/L and platelets greater than 100 x 109/L
  • Bilirubin level either normal or <1.5xULN
  • AST (SGOT) and ALT (SGPT) <2.5xULN (≤5 x ULN if liver metastases are present)
  • Serum creatinine <1.5xULN
  • Effective contraception for both, male and female pts, if the risk of conception exists
  • Recovery from all acute toxicities of prior therapies
  • Provision of written informed consent to the analysis of biological markers (registration)
  • Provision of written informed consent to enter the randomized part of the study (randomization)

Exclusion Criteria:

  • Prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or its associated tyrosine kinase
  • Prior chemotherapy with taxanes
  • Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 daysLess than 14 days since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
  • Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of the investigator, makes it inappropriate for the patient to be enrolled in the study Known severe hypersensitivity to erlotinib or any of the excipients of this product
  • Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with polysorbate 80, or any of the excipients of docetaxel
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Unable to swallow tablets
  • Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded)
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
  • As judged by the investigator, any inflammatory changes of the surface of the eye
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637910

Contact: Marina C Garassino, MD +39 0263632223
Contact: Serena Girelli, Biologist +39 0263632223

  Hide Study Locations
Ospedale Civili Riuniti Giovanni Paolo II Terminated
Sciacca, Agrigento, Italy, 92100
Fabriano Hospital Withdrawn
Fabriano, Ancona, Italy, 60044
Ospedali Riuniti Umberto I - Lancisi - Salesi Terminated
Torrette, Ancona, Italy, 60020
Oncologia A.S.L. AV1 Terminated
Ariano Irpino, Avellino, Italy, 83031
Pesenti-Fenaroli Hospital Recruiting
Alzano Lombardo, Bergamo, Italy, 24022
Contact: Giuseppe Nastasi, MD    +39 0354177235   
Principal Investigator: Giuseppe Nastasi, MD         
Ospedale di Vipiteno Terminated
Vipiteno, Bolzano, Italy, 39049
Oncologia Medica Azienda Spedali Civili Recruiting
Brescia, BS, Italy, 25123
Contact: Vittorio Ferrari, MD    +39 0303996583   
Principal Investigator: Vittorio Ferrari, MD         
Pneumologia Azienda Spedali Civili Recruiting
Brescia, BS, Italy, 25123
Contact: Vittorio Ferrari, MD    +39 0303996583   
Principal Investigator: Vittorio Ferrari, MD         
Ospedale centrale di Bolzano Recruiting
Bolzano, BZ, Italy, 39100
Contact: Emanuela Vattemi, MD    +39 0471908952   
Principal Investigator: Emanuela Vattemi, MD         
Policlinico Universitario di Monserrato Recruiting
Monserrato, Cagliari, Italy, 09042
Contact: Bruno Massidda, MD    +39 07051096208   
Principal Investigator: Bruno Massidda, MD         
Ospedale Santa Barbara Terminated
Iglesias, Carbonia Iglesias, Italy, 09016
Renzetti Hospital Recruiting
Lanciano, Chieti, Italy, 66034
Contact: Antonio Nuzzo, MD    +39 0872706220   
Principal Investigator: Antonio Nuzzo, MD         
Ospedale S. Elia Terminated
Caltanissetta, CL, Italy, 93100
San Francesco Hospital Terminated
Paola, Cosenza, Italy, 87027
Ospedale Civile di Saluzzo Savigliano Withdrawn
Saluzzo, Cuneo, Italy, 12037
Istituto Toscano Tumori Ospedale S. Giuseppe Antica Sede Recruiting
Empoli, Firenze, Italy, 50053
Contact: Gianmaria Fiorentini, MD    +39 0571702284   
Principal Investigator: Gianmaria Fiorentini, MD         
Monfalcone Hospital Terminated
Monfalcone, Gorizia, Italy, 34074
Ospedale Civile Ferrari Terminated
Casarano, Lecce, Italy, 73042
Ospedale Civile di Casalpusterlengo Terminated
Casalpusterlengo, Lodi, Italy, 26841
Ospedale S. Maria Goretti Terminated
Latina, LT, Italy, 04100
B. Eustachio Hospital Terminated
San Severino Marche, Macerata, Italy, 62027
San Vincenzo Hospital Recruiting
Taormina, Messina, Italy, 98039
Contact: Francesco Ferrau, MD    +39 0942579322331   
Principal Investigator: Francesco Ferrau, MD         
Azienda Ospedaliera Melegnano- P.O. Gorgonzola Recruiting
Gorgonzola, Milano, Italy, 20069
Contact: Luciano Isa, MD    +39 0295707207   
Principal Investigator: Luciano Isa, MD         
Legnano Hospital Recruiting
Legnano, Milano, Italy, 20025
Contact: Giambattista Roda, MD    +39 0331449306   
Principal Investigator: Gianbattista Roda, MD         
Ospedale Civile di Legnano -Presidio di Magenta Withdrawn
Magenta, Milano, Italy, 20013
San Gerardo Hospital Withdrawn
Monza, Milano, Italy, 20052
Rho Hospital - Azienda Ospedaliera Salvini-Garbagnate Terminated
Rho, Milano, Italy, 20017
Policlinico San Donato Terminated
San Donato Milanese, Milano, Italy, 20097
IRCCS Multimedica Recruiting
Sesto San Giovanni, Milano, Italy, 20099
Contact: Ornella Gottardi, MD    +39 02 24209498   
Principal Investigator: Ornella Gottardi, MD         
Ospedale Civile di Vimercate Recruiting
Vimercate, Milano, Italy, 20059
Contact: Daniele Fagnani, MD    +39 0362383230   
Principal Investigator: Daniele Fagnani, MD         
Vizzolo Predabissi Hospital Terminated
Vizzolo Predabissi, Milano, Italy, 20070
San Leonardo Hospital Terminated
Gragnano, Napoli, Italy, 80054
Ospedale Civile Vigevano Terminated
Vigevano, Pavia, Italy, 27029
Policlinico Universitario Palermo Recruiting
Palermo, PA, Italy, 90127
Contact: Sergio Palmeri, MD    +39 0916552506   
Principal Investigator: Sergio Palmeri, MD         
San Massimo Hospital Terminated
Penne, Pescara, Italy, 65017
Centro di Riferimento Oncologico Withdrawn
Aviano, Pordenone, Italy, 33081
Umberto I Hospital Recruiting
Lugo, Ravenna, Italy, 48022
Contact: Giorgio Cruciani, MD    +39 0545214081   
Principal Investigator: Giorgio Cruciani, MD         
Ospedale Civile di Siderno - ASL n°9 Locri Terminated
Siderno, Reggio Calabria, Italy, 89946
S. Sebastiano Hospital Recruiting
Correggio, Reggio Emilia, Italy, 42015
Contact: Alessandra Zoboli, MD    +39 0522 630111   
Principal Investigator: Alessandra Zoboli, MD         
Ospedale di Scandiano Terminated
Scandiano, Reggio Emilia, Italy, 42019
S. Giovanni Evangelista Hospital Recruiting
Tivoli, Roma, Italy, 00019
Contact: Franco Spremberg, MD    +39 07743164353   
Principal Investigator: Franco Spremberg, MD         
ASL SA1 -P.O. Umberto I Recruiting
Nocera Inferiore, Salerno, Italy, 84014
Contact: Giuseppe Grimaldi, MD    +39 0819213331   
Principal Investigator: Giuseppe Grimaldi, MD         
Presidio Ospedaliero San Luca Terminated
Vallo della Lucania, Salerno, Italy, 84078
Ospedale Valdichiana "Nottola" Recruiting
Montepulciano, Siena, Italy, 53045
Contact: Sergio Crispino, MD    +39 0578713111   
Principal Investigator: Sergio Crispino, MD         
Ospedale Valdelsa "Campostaggia" Recruiting
Poggibonsi, Siena, Italy, 53036
Contact: Sergio Crispino, MD    +39 0577586927   
Principal Investigator: Sergio Crispino, MD         
Ospedale di Terni Recruiting
Terni, TR, Italy, 05100
Contact: Fausto Roila, MD    +39 0744205584   
Principal Investigator: Fausto Roila, MD         
Multimedia Santa Maria Recruiting
Castellanza, Varese, Italy, 21053
Contact: Ornella Gottardi, MD    +39 0331476111   
Principal Investigator: Ornella Gottardi, MD         
Azienda Ospedaliera Busto Arsizio Recruiting
Saronno, Varese, Italy, 21047
Contact: Claudio Verusio, MD    +39 029613576   
Principal Investigator: Claudio Verusio, MD         
Umberto I Hospital Terminated
Mestre, Venezia, Italy, 30174
Ospedale Mater Salutis Recruiting
Legnago, Verona, Italy, 37045
Contact: Andrea Bonetti, MD    0039.0442632418   
Principal Investigator: Andrea Bonetti, MD         
Ospedale Policlinico G.B. Rossi Terminated
Verona, VR, Italy, 37134
S. Giovanni di Dio Hospital Withdrawn
Agrigento, Italy, 92100
Ospedale San Donato Terminated
Arezzo, Italy, 52100
Azienda Ospedaliera Universitaria Consorziale Policlinico Withdrawn
Bari, Italy, 70124
Fatebenefratelli Hospital Terminated
Benevento, Italy, 82100
G. Rummo Hospital Recruiting
Benevento, Italy, 82100
Contact: Bruno Daniele, MD    +39 082457724   
Principal Investigator: Bruno Daniele, MD         
Ospedali Riuniti Recruiting
Bergamo, Italy, 24128
Contact: Roberto Labianca, MD    +39 035 269724859   
Principal Investigator: Roberto Labianca, MD         
Armando Businco Oncological Hospital Recruiting
Cagliari, Italy, 09100
Contact: Efisio Defraia, MD    +39 0706095332   
Principal Investigator: Efisio Defraia, MD         
Presidio Ospedaliero Cardarelli ASL 3 Terminated
Campobasso, Italy, 86100
Sant'Anna Hospital Withdrawn
Como, Italy, 22100
Mariano Santo Hospital Withdrawn
Cosenza, Italy, 87100
Ospedale Maggiore di Crema Terminated
Crema, Italy, 26013
S. Croce e Carle Hospital Recruiting
Cuneo, Italy, 12100
Contact: Ida Colantonio, MD    +39 0171616739   
Principal Investigator: Ida Colantonio, MD         
A.O.U. S. Anna Terminated
Ferrara, Italy, 44100
A.O.U. Careggi Terminated
Firenze, Italy, 50130
Azienda Ospedaliero Universitaria Careggi Terminated
Firenze, Italy, 50130
A.O. San Martino Terminated
Genova, Italy, 16100
Galliera Hospital Recruiting
Genova, Italy, 16128
Contact: Andrea Decensi, MD    +39 010 5634501   
Principal Investigator: Andrea Decensi, MD         
F. Veneziale Hospital Recruiting
Isernia, Italy, 86170
Contact: Liberato Di Lullo, MD    +39 0865442212   
Principal Investigator: Liberato Di Lullo, MD         
Azienda Ospedaliera di Lecco Recruiting
Lecco, Italy, 23900
Contact: Antonio Ardizzoia, MD    +39 0341489900   
Principal Investigator: Antonio Ardizzoia, MD         
Fatebenefratelli and Ophthalmic Hospital Recruiting
Milano, Italy, 20121
Contact: Gabriella Farina, MD    +39 0263632223   
Contact: Marina C Garassino, MD    +39 0263632223   
Principal Investigator: Gabriella Farina, MD         
Fondazione Ospedale Maggiore Policlinico - Mangiagalli e Regina Elena Recruiting
Milano, Italy, 20122
Contact: Maurizio Tomirotti, MD    +39 0255034670   
Principal Investigator: Maurizio Tomirotti, MD         
San Paolo Hospital Recruiting
Milano, Italy, 20142
Contact: Paolo Foa, MD    +39 0250323085   
Principal Investigator: Paolo Foa, MD         
San Carlo Borromeo Hospital Recruiting
Milano, Italy, 20153
Contact: Maria Cristina Locatelli, MD    +39 0240222270;   
Principal Investigator: Maria Cristina Locatelli Locatelli, MD         
Azienda Ospedaliera Luigi Sacco Polo Universitario Recruiting
Milano, Italy, 20157
Contact: Elena Piazza, MD    +39 0239042493   
Principal Investigator: Elena Piazza, MD         
A.O. Monaldi Terminated
Napoli, Italy, 80131
Cardarelli Hospital Terminated
Napoli, Italy, 80131
D. Cotugno Hospital Terminated
Napoli, Italy, 80131
San Gennaro Hospital - ASL NA 1 Terminated
Napoli, Italy, 80136
Ospedale Maggiore della Carità Recruiting
Novara, Italy, 28100
Contact: Oscar Alabiso, MD    +39 03213733984   
Principal Investigator: Oscar Alabiso, MD         
Azienda Ospedaliera Universitaria Presidio "Paolo Giaccone" Terminated
Palermo, Italy, 90127
Presidio Ospedaliero "M. Ascoli" ARNAS Civico Terminated
Palermo, Italy, 90127
Centro Oncologico "La Maddalena" Terminated
Palermo, Italy, 90146
S. Maria della Misericordia Hospital Terminated
Perugia, Italy, 06156
Piacenza Hospital Recruiting
Piacenza, Italy, 29100
Contact: Luigi Cavanna, MD    +39 0523302697   
Principal Investigator: Luigi Cavanna, MD         
S. Maria degli Angeli Hospital Recruiting
Pordenone, Italy, 33170
Contact: Salvatore Tumolo, MD    +39 0434399464   
Principal Investigator: Salvatore Tumolo, MD         
Ospedale Civile Santa Maria delle Croci Recruiting
Ravenna, Italy, 48100
Contact: Giorgio Cruciani, MD    0039.054428530   
Principal Investigator: Giorgio Cruciani, MD         
Arcispedale S. Maria Nuova Withdrawn
Reggio Emilia, Italy, 42100
Ospedale San Pietro Fatebenefratelli Recruiting
Roma, Italy, 00100
Contact: Ida Pavese, MD    0039.0633582831   
Principal Investigator: Ida Pavese, MD         
Pneumologia Oncologica II-San Camillo Forlanini Hospital Terminated
Roma, Italy, 00149
Oncologia Medica-San Camillo Forlanini Hopsital Recruiting
Roma, Italy, 00152
Contact: Cora N Sternberg, MD    +39 0658704317   
Principal Investigator: Cora N Sternberg, MD         
Università Campus Bio-Medico Terminated
Roma, Italy, 00155
Policlinico Umberto I Recruiting
Roma, Italy, 00161
Contact: Enrico Cortesi, MD    +39 064462982   
Principal Investigator: Enrico Cortesi, MD         
Policlinico Umberto I Recruiting
Roma, Italy, 00161
Contact: Flavia Longo, MD    +39 0649970273   
Principal Investigator: Flavia Longo, MD         
S. Giovanni - Addolorata Hospital Recruiting
Roma, Italy, 00184
Contact: Maria Mauri, MD    +39 0677052929   
Principal Investigator: Maria Mauri, MD         
Azienda Ospedaliera S. Giovanni di Dio e Ruggi d'Aragona Terminated
Salerno, Italy, 84122
Ospedale Civile SS. Annunziata Recruiting
Sassari, Italy, 07100
Contact: Antonio Contu, MD    +39 0792061638   
Principal Investigator: Antonio Contu, MD         
Universita' di Sassari Oncologia Medica Recruiting
Sassari, Italy, 07100
Contact: Antonio Farris, MD    0039.079228382   
Principal Investigator: Antonio Farris, MD         
Ospedale Morelli Recruiting
Sondrio, Italy, 23035
Contact: Giuseppe Valmadre, MD    0039.0342808322   
Principal Investigator: Giuseppe Valmadre, MD         
Sondrio Hospital-Azienda Ospedaliera Valtellina e Valchiavenna Recruiting
Sondrio, Italy, 23100
Contact: Alessandro Bertolini, MD    +39 0342521594   
Principal Investigator: Alessandro Bertolini, MD         
A.O.U. San Giovanni Battista Molinette Recruiting
Torino, Italy, 10134
Contact: Libero Ciuffreda, MD    0039.0116334250   
Principal Investigator: Libero Ciuffreda, MD         
Ospedale di Circolo Terminated
Varese, Italy, 21100
SS. Giovanni e Paolo Hospital Terminated
Venezia, Italy, 30122
San Bartolo Hospital Withdrawn
Vicenza, Italy, 36100
Belcolle Hospital Recruiting
Viterbo, Italy, 01100
Contact: Luca Moscetti, MD    +39 0761339040   
Principal Investigator: Luca Moscetti, MD         
Sponsors and Collaborators
Fatebenefratelli and Ophthalmic Hospital
Mario Negri Institute for Pharmacological Research
Niguarda Hospital
Principal Investigator: Alberto Scanni, MD Fatebenefratelli and Ophthalmic Hospital

Crinò L; Zatloukal P; Reck M; Pesek M; Thomson J; Ford H; Hirsch F; Duffield E; Armour A; Cullen M. Gefitinib (Iressa) versus vinorelbine in chemonaive elderly pts with advanced NSCLC (INVITE): a randomized phase II study: B3-04. Journal of Thoracic Oncology Volume 2(8) Supplement 4 August 2007p S341 number 8

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Scanni Alberto, Alberto Scanni MD, Fatebenefratelli and Ophthalmic Hospital Identifier: NCT00637910     History of Changes
Other Study ID Numbers: FARM6F5JER
2007-004786-17 ( EudraCT Number )
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012

Keywords provided by Scanni Alberto, Fatebenefratelli and Ophthalmic Hospital:
Advanced NSCLC
EGFR copy number
Kras mutations
EGRF mutations

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors