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Tarceva Italian Lung Optimization tRial (TAILOR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Fatebenefratelli and Ophthalmic Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Mario Negri Institute for Pharmacological Research
Niguarda Hospital
Information provided by (Responsible Party):
Scanni Alberto, Fatebenefratelli and Ophthalmic Hospital
ClinicalTrials.gov Identifier:
NCT00637910
First received: March 12, 2008
Last updated: February 23, 2012
Last verified: February 2012
  Purpose
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 Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Drug: Erlotinib
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fatebenefratelli and Ophthalmic Hospital:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 12 months after the last patient is randomized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: with 4 years and 12 months after the last patient is randomized ] [ Designated as safety issue: No ]
  • Response assessed with RECIST criteria [ Time Frame: within 4 years ] [ Designated as safety issue: No ]
  • Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires [ Time Frame: within 4 years ] [ Designated as safety issue: No ]
  • Toxicity, graded according to the NCI-CTAE version 3.0 [ Time Frame: within 4 years ] [ Designated as safety issue: Yes ]
  • Frequency and nature of serious adverse reactions [ Time Frame: within 4 years ] [ Designated as safety issue: Yes ]
  • Premature withdrawals [ Time Frame: within 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 850
Study Start Date: November 2007
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637910

  Hide Study Locations
Locations
Italy
Ospedale Civili Riuniti Giovanni Paolo II
Sciacca, Agrigento, Italy, 92100
Ospedali Riuniti Umberto I - Lancisi - Salesi
Torrette, Ancona, Italy, 60020
Oncologia A.S.L. AV1
Ariano Irpino, Avellino, Italy, 83031
Pesenti-Fenaroli Hospital
Alzano Lombardo, Bergamo, Italy, 24022
Ospedale di Vipiteno
Vipiteno, Bolzano, Italy, 39049
Oncologia Medica Azienda Spedali Civili
Brescia, BS, Italy, 25123
Pneumologia Azienda Spedali Civili
Brescia, BS, Italy, 25123
Ospedale centrale di Bolzano
Bolzano, BZ, Italy, 39100
Policlinico Universitario di Monserrato
Monserrato, Cagliari, Italy, 09042
Ospedale Santa Barbara
Iglesias, Carbonia Iglesias, Italy, 09016
Renzetti Hospital
Lanciano, Chieti, Italy, 66034
Ospedale S. Elia
Caltanissetta, CL, Italy, 93100
San Francesco Hospital
Paola, Cosenza, Italy, 87027
Istituto Toscano Tumori Ospedale S. Giuseppe Antica Sede
Empoli, Firenze, Italy, 50053
Monfalcone Hospital
Monfalcone, Gorizia, Italy, 34074
Ospedale Civile Ferrari
Casarano, Lecce, Italy, 73042
Ospedale Civile di Casalpusterlengo
Casalpusterlengo, Lodi, Italy, 26841
Ospedale S. Maria Goretti
Latina, LT, Italy, 04100
B. Eustachio Hospital
San Severino Marche, Macerata, Italy, 62027
San Vincenzo Hospital
Taormina, Messina, Italy, 98039
Azienda Ospedaliera Melegnano- P.O. Gorgonzola
Gorgonzola, Milano, Italy, 20069
Legnano Hospital
Legnano, Milano, Italy, 20025
Rho Hospital - Azienda Ospedaliera Salvini-Garbagnate
Rho, Milano, Italy, 20017
Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097
IRCCS Multimedica
Sesto San Giovanni, Milano, Italy, 20099
Ospedale Civile di Vimercate
Vimercate, Milano, Italy, 20059
Vizzolo Predabissi Hospital
Vizzolo Predabissi, Milano, Italy, 20070
San Leonardo Hospital
Gragnano, Napoli, Italy, 80054
Ospedale Civile Vigevano
Vigevano, Pavia, Italy, 27029
Policlinico Universitario Palermo
Palermo, PA, Italy, 90127
San Massimo Hospital
Penne, Pescara, Italy, 65017
Umberto I Hospital
Lugo, Ravenna, Italy, 48022
Ospedale Civile di Siderno - ASL n°9 Locri
Siderno, Reggio Calabria, Italy, 89946
S. Sebastiano Hospital
Correggio, Reggio Emilia, Italy, 42015
Ospedale di Scandiano
Scandiano, Reggio Emilia, Italy, 42019
S. Giovanni Evangelista Hospital
Tivoli, Roma, Italy, 00019
ASL SA1 -P.O. Umberto I
Nocera Inferiore, Salerno, Italy, 84014
Presidio Ospedaliero San Luca
Vallo della Lucania, Salerno, Italy, 84078
Ospedale Valdichiana "Nottola"
Montepulciano, Siena, Italy, 53045
Ospedale Valdelsa "Campostaggia"
Poggibonsi, Siena, Italy, 53036
Ospedale di Terni
Terni, TR, Italy, 05100
Multimedia Santa Maria
Castellanza, Varese, Italy, 21053
Azienda Ospedaliera Busto Arsizio
Saronno, Varese, Italy, 21047
Umberto I Hospital
Mestre, Venezia, Italy, 30174
Ospedale Mater Salutis
Legnago, Verona, Italy, 37045
Ospedale Policlinico G.B. Rossi
Verona, VR, Italy, 37134
Ospedale San Donato
Arezzo, Italy, 52100
Fatebenefratelli Hospital
Benevento, Italy, 82100
G. Rummo Hospital
Benevento, Italy, 82100
Ospedali Riuniti
Bergamo, Italy, 24128
Armando Businco Oncological Hospital
Cagliari, Italy, 09100
Presidio Ospedaliero Cardarelli ASL 3
Campobasso, Italy, 86100
Ospedale Maggiore di Crema
Crema, Italy, 26013
S. Croce e Carle Hospital
Cuneo, Italy, 12100
A.O.U. S. Anna
Ferrara, Italy, 44100
A.O.U. Careggi
Firenze, Italy, 50130
Azienda Ospedaliero Universitaria Careggi
Firenze, Italy, 50130
A.O. San Martino
Genova, Italy, 16100
Galliera Hospital
Genova, Italy, 16128
F. Veneziale Hospital
Isernia, Italy, 86170
Azienda Ospedaliera di Lecco
Lecco, Italy, 23900
Fatebenefratelli and Ophthalmic Hospital
Milano, Italy, 20121
Fondazione Ospedale Maggiore Policlinico - Mangiagalli e Regina Elena
Milano, Italy, 20122
San Paolo Hospital
Milano, Italy, 20142
San Carlo Borromeo Hospital
Milano, Italy, 20153
Azienda Ospedaliera Luigi Sacco Polo Universitario
Milano, Italy, 20157
A.O. Monaldi
Napoli, Italy, 80131
Cardarelli Hospital
Napoli, Italy, 80131
D. Cotugno Hospital
Napoli, Italy, 80131
San Gennaro Hospital - ASL NA 1
Napoli, Italy, 80136
Ospedale Maggiore della Carità
Novara, Italy, 28100
Azienda Ospedaliera Universitaria Presidio "Paolo Giaccone"
Palermo, Italy, 90127
Presidio Ospedaliero "M. Ascoli" ARNAS Civico
Palermo, Italy, 90127
Centro Oncologico "La Maddalena"
Palermo, Italy, 90146
S. Maria della Misericordia Hospital
Perugia, Italy, 06156
Piacenza Hospital
Piacenza, Italy, 29100
S. Maria degli Angeli Hospital
Pordenone, Italy, 33170
Ospedale Civile Santa Maria delle Croci
Ravenna, Italy, 48100
Ospedale San Pietro Fatebenefratelli
Roma, Italy, 00100
Pneumologia Oncologica II-San Camillo Forlanini Hospital
Roma, Italy, 00149
Oncologia Medica-San Camillo Forlanini Hopsital
Roma, Italy, 00152
Università Campus Bio-Medico
Roma, Italy, 00155
Policlinico Umberto I
Roma, Italy, 00161
S. Giovanni - Addolorata Hospital
Roma, Italy, 00184
Azienda Ospedaliera S. Giovanni di Dio e Ruggi d'Aragona
Salerno, Italy, 84122
Ospedale Civile SS. Annunziata
Sassari, Italy, 07100
Universita' di Sassari Oncologia Medica
Sassari, Italy, 07100
Ospedale Morelli
Sondrio, Italy, 23035
Sondrio Hospital-Azienda Ospedaliera Valtellina e Valchiavenna
Sondrio, Italy, 23100
A.O.U. San Giovanni Battista Molinette
Torino, Italy, 10134
Ospedale di Circolo
Varese, Italy, 21100
SS. Giovanni e Paolo Hospital
Venezia, Italy, 30122
Belcolle Hospital
Viterbo, Italy, 01100
Sponsors and Collaborators
Fatebenefratelli and Ophthalmic Hospital
Mario Negri Institute for Pharmacological Research
Niguarda Hospital
Investigators
Principal Investigator: Alberto Scanni, MD Fatebenefratelli and Ophthalmic Hospital
  More Information

Publications:
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 ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Scanni Alberto, Alberto Scanni MD, Fatebenefratelli and Ophthalmic Hospital
ClinicalTrials.gov Identifier: NCT00637910     History of Changes
Other Study ID Numbers: FARM6F5JER  2007-004786-17 
Study First Received: March 12, 2008
Last Updated: February 23, 2012
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by Fatebenefratelli and Ophthalmic Hospital:
Advanced NSCLC
EGFR
EGFR copy number
Kras mutations
EGRF mutations
Docetaxel
Erlotinib
Polymorphisms

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

ClinicalTrials.gov processed this record on December 06, 2016