Tarceva Italian Lung Optimization tRial

NCT00637910 | Unknown Phase 3 DMC

• 2 other identifiers: FARM6F5JER2007-004786-17
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 105

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.

Conditions

Non Small Cell Lung Cancer (NSCLC)

Keywords

Advanced NSCLC; EGFR; EGFR copy number; Kras mutations; EGRF mutations; Docetaxel; Erlotinib; Polymorphisms

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  12 months after the last patient is randomized

Secondary Outcomes (6)

• Progression Free Survival

  with 4 years and 12 months after the last patient is randomized

• Response assessed with RECIST criteria

  within 4 years

• Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires

  within 4 years

• Toxicity, graded according to the NCI-CTAE version 3.0

  within 4 years

• Frequency and nature of serious adverse reactions

  within 4 years

Study Arms (2)

Erlotinib Arm

EXPERIMENTAL

Drug: Erlotinib

Docetaxel Arm

ACTIVE COMPARATOR

Drug: Docetaxel

Interventions

Erlotinib DRUG

Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops

Also known as: Tarceva

Erlotinib Arm

Docetaxel DRUG

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

Also known as: Taxotere

Docetaxel Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatebenefratelli and Ophthalmic Hospital: lead
• Mario Negri Institute for Pharmacological Research: collaborator
• Niguarda Hospital: collaborator

Study Sites (105)

S. Giovanni di Dio Hospital

Agrigento, Agrigento, 92100, Italy

WITHDRAWN

Ospedale Civili Riuniti Giovanni Paolo II

Sciacca, Agrigento, 92100, Italy

TERMINATED

Fabriano Hospital

Fabriano, Ancona, 60044, Italy

WITHDRAWN

Ospedali Riuniti Umberto I - Lancisi - Salesi

Torrette, Ancona, 60020, Italy

TERMINATED

Oncologia A.S.L. AV1

Ariano Irpino, Avellino, 83031, Italy

TERMINATED

Azienda Ospedaliera Universitaria Consorziale Policlinico

Bari, Bari, 70124, Italy

WITHDRAWN

Fatebenefratelli Hospital

Benevento, Benevento, 82100, Italy

TERMINATED

G. Rummo Hospital

Benevento, Benevento, 82100, Italy

RECRUITING

Pesenti-Fenaroli Hospital

Alzano Lombardo, Bergamo, 24022, Italy

RECRUITING

Ospedali Riuniti

Bergamo, Bergamo, 24128, Italy

RECRUITING

Ospedale di Vipiteno

Sterzing, Bolzano, 39049, Italy

TERMINATED

Oncologia Medica Azienda Spedali Civili

Brescia, BS, 25123, Italy

RECRUITING

Pneumologia Azienda Spedali Civili

Brescia, BS, 25123, Italy

RECRUITING

Ospedale centrale di Bolzano

Bolzano, BZ, 39100, Italy

RECRUITING

Armando Businco Oncological Hospital

Cagliari, Cagliari, 09100, Italy

RECRUITING

Policlinico Universitario di Monserrato

Monserrato, Cagliari, 09042, Italy

RECRUITING

Presidio Ospedaliero Cardarelli ASL 3

Campobasso, Campobasso, 86100, Italy

TERMINATED

Ospedale Santa Barbara

Iglesias, Carbonia Iglesias, 09016, Italy

TERMINATED

Renzetti Hospital

Lanciano, Chieti, 66034, Italy

RECRUITING

Ospedale S. Elia

Caltanissetta, CL, 93100, Italy

TERMINATED

Sant'Anna Hospital

Como, Como, 22100, Italy

WITHDRAWN

Mariano Santo Hospital

Cosenza, Cosenza, 87100, Italy

WITHDRAWN

San Francesco Hospital

Paola, Cosenza, 87027, Italy

TERMINATED

Ospedale Maggiore di Crema

Crema, Crema, 26013, Italy

TERMINATED

S. Croce e Carle Hospital

Cuneo, Cuneo, 12100, Italy

RECRUITING

Ospedale Civile di Saluzzo Savigliano

Saluzzo, Cuneo, 12037, Italy

WITHDRAWN

Istituto Toscano Tumori Ospedale S. Giuseppe Antica Sede

Empoli, Firenze, 50053, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, Firenze, 50130, Italy

TERMINATED

Galliera Hospital

Genova, Genova, 16128, Italy

RECRUITING

Monfalcone Hospital

Monfalcone, Gorizia, 34074, Italy

TERMINATED

F. Veneziale Hospital

Isernia, Isernia, 86170, Italy

RECRUITING

Ospedale Civile Ferrari

Casarano, Lecce, 73042, Italy

TERMINATED

Azienda Ospedaliera di Lecco

Lecco, Lecco, 23900, Italy

RECRUITING

Ospedale Civile di Casalpusterlengo

Casalpusterlengo, Lodi, 26841, Italy

TERMINATED

Ospedale S. Maria Goretti

Latina, LT, 04100, Italy

TERMINATED

B. Eustachio Hospital

San Severino Marche, Macerata, 62027, Italy

TERMINATED

San Vincenzo Hospital

Taormina, Messina, 98039, Italy

RECRUITING

Azienda Ospedaliera Melegnano- P.O. Gorgonzola

Gorgonzola, Milano, 20069, Italy

RECRUITING

Legnano Hospital

Legnano, Milano, 20025, Italy

RECRUITING

Ospedale Civile di Legnano -Presidio di Magenta

Magenta, Milano, 20013, Italy

WITHDRAWN

Fatebenefratelli and Ophthalmic Hospital

Milan, Milano, 20121, Italy

RECRUITING

Fondazione Ospedale Maggiore Policlinico - Mangiagalli e Regina Elena

Milan, Milano, 20122, Italy

RECRUITING

San Paolo Hospital

Milan, Milano, 20142, Italy

RECRUITING

San Carlo Borromeo Hospital

Milan, Milano, 20153, Italy

RECRUITING

Azienda Ospedaliera Luigi Sacco Polo Universitario

Milan, Milano, 20157, Italy

RECRUITING

San Gerardo Hospital

Monza, Milano, 20052, Italy

WITHDRAWN

Rho Hospital - Azienda Ospedaliera Salvini-Garbagnate

Rho, Milano, 20017, Italy

TERMINATED

Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

TERMINATED

IRCCS Multimedica

Sesto San Giovanni, Milano, 20099, Italy

RECRUITING

Ospedale Civile di Vimercate

Vimercate, Milano, 20059, Italy

RECRUITING

Vizzolo Predabissi Hospital

Vizzolo Predabissi, Milano, 20070, Italy

TERMINATED

San Leonardo Hospital

Gragnano, Napoli, 80054, Italy

TERMINATED

Cardarelli Hospital

Napoli, Napoli, 80131, Italy

TERMINATED

D. Cotugno Hospital

Napoli, Napoli, 80131, Italy

TERMINATED

San Gennaro Hospital - ASL NA 1

Napoli, Napoli, 80136, Italy

TERMINATED

Ospedale Maggiore della Carità

Novara, Novara, 28100, Italy

RECRUITING

Azienda Ospedaliera Universitaria Presidio "Paolo Giaccone"

Palermo, Palermo, 90127, Italy

TERMINATED

Presidio Ospedaliero "M. Ascoli" ARNAS Civico

Palermo, Palermo, 90127, Italy

TERMINATED

Centro Oncologico "La Maddalena"

Palermo, Palermo, 90146, Italy

TERMINATED

Ospedale Civile Vigevano

Vigevano, Pavia, 27029, Italy

TERMINATED

Policlinico Universitario Palermo

Palermo, PA, 90127, Italy

RECRUITING

S. Maria della Misericordia Hospital

Perugia, Perugia, 06156, Italy

TERMINATED

San Massimo Hospital

Penne, Pescara, 65017, Italy

TERMINATED

Piacenza Hospital

Piacenza, Piacenza, 29100, Italy

RECRUITING

Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

WITHDRAWN

S. Maria degli Angeli Hospital

Pordenone, Pordenone, 33170, Italy

RECRUITING

Umberto I Hospital

Lugo, Ravenna, 48022, Italy

RECRUITING

Ospedale Civile di Siderno - ASL n°9 Locri

Siderno, Reggio Calabria, 89946, Italy

TERMINATED

S. Sebastiano Hospital

Correggio, Reggio Emilia, 42015, Italy

RECRUITING

Arcispedale S. Maria Nuova

Reggio Emilia, Reggio Emilia, 42100, Italy

WITHDRAWN

Ospedale di Scandiano

Scandiano, Reggio Emilia, 42019, Italy

TERMINATED

Pneumologia Oncologica II-San Camillo Forlanini Hospital

Roma, Roma, 00149, Italy

TERMINATED

Oncologia Medica-San Camillo Forlanini Hopsital

Roma, Roma, 00152, Italy

RECRUITING

Università Campus Bio-Medico

Roma, Roma, 00155, Italy

TERMINATED

Policlinico Umberto I

Roma, Roma, 00161, Italy

RECRUITING

Policlinico Umberto I

Roma, Roma, 00161, Italy

RECRUITING

S. Giovanni - Addolorata Hospital

Roma, Roma, 00184, Italy

RECRUITING

S. Giovanni Evangelista Hospital

Tivoli, Roma, 00019, Italy

RECRUITING

ASL SA1 -P.O. Umberto I

Nocera Inferiore, Salerno, 84014, Italy

RECRUITING

Azienda Ospedaliera S. Giovanni di Dio e Ruggi d'Aragona

Salerno, Salerno, 84122, Italy

TERMINATED

Presidio Ospedaliero San Luca

Vallo della Lucania, Salerno, 84078, Italy

TERMINATED

Ospedale Civile SS. Annunziata

Sassari, Sassari, 07100, Italy

RECRUITING

Ospedale Valdichiana "Nottola"

Montepulciano, Siena, 53045, Italy

RECRUITING

Ospedale Valdelsa "Campostaggia"

Poggibonsi, Siena, 53036, Italy

RECRUITING

Sondrio Hospital-Azienda Ospedaliera Valtellina e Valchiavenna

Sondrio, Sondrio, 23100, Italy

RECRUITING

Ospedale di Terni

Terni, TR, 05100, Italy

RECRUITING

Multimedia Santa Maria

Castellanza, Varese, 21053, Italy

RECRUITING

Azienda Ospedaliera Busto Arsizio

Saronno, Varese, 21047, Italy

RECRUITING

Ospedale di Circolo

Varese, Varese, 21100, Italy

TERMINATED

Umberto I Hospital

Mestre, Venezia, 30174, Italy

TERMINATED

SS. Giovanni e Paolo Hospital

Venezia, Venezia, 30122, Italy

TERMINATED

Ospedale Mater Salutis

Legnago, Verona, 37045, Italy

RECRUITING

San Bartolo Hospital

Vicenza, Vicenza, 36100, Italy

WITHDRAWN

Belcolle Hospital

Viterbo, Viterbo, 01100, Italy

RECRUITING

Ospedale Policlinico G.B. Rossi

Verona, VR, 37134, Italy

TERMINATED

Ospedale San Donato

Arezzo, 52100, Italy

TERMINATED

A.O.U. S. Anna

Ferrara, 44100, Italy

TERMINATED

A.O.U. Careggi

Florence, 50130, Italy

TERMINATED

A.O. San Martino

Genova, 16100, Italy

TERMINATED

A.O. Monaldi

Napoli, 80131, Italy

TERMINATED

Ospedale Civile Santa Maria delle Croci

Ravenna, 48100, Italy

RECRUITING

Ospedale San Pietro Fatebenefratelli

Roma, 00100, Italy

RECRUITING

Universita' di Sassari Oncologia Medica

Sassari, 07100, Italy

RECRUITING

Ospedale Morelli

Sondrio, 23035, Italy

RECRUITING

A.O.U. San Giovanni Battista Molinette

Torino, 10134, Italy

RECRUITING

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Alberto Scanni, MD

  Fatebenefratelli and Ophthalmic Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina C Garassino, MD

CONTACT

+39 0263632223; marina.garassino@fbf.milano.it

Serena Girelli, Biologist

CONTACT

+39 0263632223; datamanager@fbf.milano.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alberto Scanni MD

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 18, 2008
• Study Start: November 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2013
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

IT (105)