TAILOR: Tarceva Italian Lung Optimization tRial

• Sponsor: Fatebenefratelli and Ophthalmic Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00637910
• Collaborator: Mario Negri Institute for Pharmacological Research (Other), Niguarda Hospital (Other)
• Enrollment: 850
• Locations: 105
• Arms: 2
• Duration (Months): 63
• Patients Per Site: 8.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 2007
• Anticipated Primary Completion Date: Feb 1, 2012
• Anticipated Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erlotinib Arm	Drug: Erlotinib; Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops; Other Names: 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 Names: Taxotere

Outcome Measures

Primary Outcome Measures

1. Overall Survival [12 months after the last patient is randomized]

Secondary Outcome Measures

1. Progression Free Survival [with 4 years and 12 months after the last patient is randomized]

2. Response assessed with RECIST criteria [within 4 years]

3. Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires [within 4 years]

4. Toxicity, graded according to the NCI-CTAE version 3.0 [within 4 years]

5. Frequency and nature of serious adverse reactions [within 4 years]

6. Premature withdrawals [within 4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Civili Riuniti Giovanni Paolo II	Sciacca	Agrigento	Italy	92100
2	Fabriano Hospital	Fabriano	Ancona	Italy	60044
3	Ospedali Riuniti Umberto I - Lancisi - Salesi	Torrette	Ancona	Italy	60020
4	Oncologia A.S.L. AV1	Ariano Irpino	Avellino	Italy	83031
5	Pesenti-Fenaroli Hospital	Alzano Lombardo	Bergamo	Italy	24022
6	Ospedale di Vipiteno	Vipiteno	Bolzano	Italy	39049
7	Oncologia Medica Azienda Spedali Civili	Brescia	BS	Italy	25123
8	Pneumologia Azienda Spedali Civili	Brescia	BS	Italy	25123
9	Ospedale centrale di Bolzano	Bolzano	BZ	Italy	39100
10	Policlinico Universitario di Monserrato	Monserrato	Cagliari	Italy	09042
11	Ospedale Santa Barbara	Iglesias	Carbonia Iglesias	Italy	09016
12	Renzetti Hospital	Lanciano	Chieti	Italy	66034
13	Ospedale S. Elia	Caltanissetta	CL	Italy	93100
14	San Francesco Hospital	Paola	Cosenza	Italy	87027
15	Ospedale Civile di Saluzzo Savigliano	Saluzzo	Cuneo	Italy	12037
16	Istituto Toscano Tumori Ospedale S. Giuseppe Antica Sede	Empoli	Firenze	Italy	50053
17	Monfalcone Hospital	Monfalcone	Gorizia	Italy	34074
18	Ospedale Civile Ferrari	Casarano	Lecce	Italy	73042
19	Ospedale Civile di Casalpusterlengo	Casalpusterlengo	Lodi	Italy	26841
20	Ospedale S. Maria Goretti	Latina	LT	Italy	04100
21	B. Eustachio Hospital	San Severino Marche	Macerata	Italy	62027
22	San Vincenzo Hospital	Taormina	Messina	Italy	98039
23	Azienda Ospedaliera Melegnano- P.O. Gorgonzola	Gorgonzola	Milano	Italy	20069
24	Legnano Hospital	Legnano	Milano	Italy	20025
25	Ospedale Civile di Legnano -Presidio di Magenta	Magenta	Milano	Italy	20013
26	San Gerardo Hospital	Monza	Milano	Italy	20052
27	Rho Hospital - Azienda Ospedaliera Salvini-Garbagnate	Rho	Milano	Italy	20017
28	Policlinico San Donato	San Donato Milanese	Milano	Italy	20097
29	IRCCS Multimedica	Sesto San Giovanni	Milano	Italy	20099
30	Ospedale Civile di Vimercate	Vimercate	Milano	Italy	20059
31	Vizzolo Predabissi Hospital	Vizzolo Predabissi	Milano	Italy	20070
32	San Leonardo Hospital	Gragnano	Napoli	Italy	80054
33	Ospedale Civile Vigevano	Vigevano	Pavia	Italy	27029
34	Policlinico Universitario Palermo	Palermo	PA	Italy	90127
35	San Massimo Hospital	Penne	Pescara	Italy	65017
36	Centro di Riferimento Oncologico	Aviano	Pordenone	Italy	33081
37	Umberto I Hospital	Lugo	Ravenna	Italy	48022
38	Ospedale Civile di Siderno - ASL n°9 Locri	Siderno	Reggio Calabria	Italy	89946
39	S. Sebastiano Hospital	Correggio	Reggio Emilia	Italy	42015
40	Ospedale di Scandiano	Scandiano	Reggio Emilia	Italy	42019
41	S. Giovanni Evangelista Hospital	Tivoli	Roma	Italy	00019
42	ASL SA1 -P.O. Umberto I	Nocera Inferiore	Salerno	Italy	84014
43	Presidio Ospedaliero San Luca	Vallo della Lucania	Salerno	Italy	84078
44	Ospedale Valdichiana "Nottola"	Montepulciano	Siena	Italy	53045
45	Ospedale Valdelsa "Campostaggia"	Poggibonsi	Siena	Italy	53036
46	Ospedale di Terni	Terni	TR	Italy	05100
47	Multimedia Santa Maria	Castellanza	Varese	Italy	21053
48	Azienda Ospedaliera Busto Arsizio	Saronno	Varese	Italy	21047
49	Umberto I Hospital	Mestre	Venezia	Italy	30174
50	Ospedale Mater Salutis	Legnago	Verona	Italy	37045
51	Ospedale Policlinico G.B. Rossi	Verona	VR	Italy	37134
52	S. Giovanni di Dio Hospital	Agrigento		Italy	92100
53	Ospedale San Donato	Arezzo		Italy	52100
54	Azienda Ospedaliera Universitaria Consorziale Policlinico	Bari		Italy	70124
55	Fatebenefratelli Hospital	Benevento		Italy	82100
56	G. Rummo Hospital	Benevento		Italy	82100
57	Ospedali Riuniti	Bergamo		Italy	24128
58	Armando Businco Oncological Hospital	Cagliari		Italy	09100
59	Presidio Ospedaliero Cardarelli ASL 3	Campobasso		Italy	86100
60	Sant'Anna Hospital	Como		Italy	22100
61	Mariano Santo Hospital	Cosenza		Italy	87100
62	Ospedale Maggiore di Crema	Crema		Italy	26013
63	S. Croce e Carle Hospital	Cuneo		Italy	12100
64	A.O.U. S. Anna	Ferrara		Italy	44100
65	A.O.U. Careggi	Firenze		Italy	50130
66	Azienda Ospedaliero Universitaria Careggi	Firenze		Italy	50130
67	A.O. San Martino	Genova		Italy	16100
68	Galliera Hospital	Genova		Italy	16128
69	F. Veneziale Hospital	Isernia		Italy	86170
70	Azienda Ospedaliera di Lecco	Lecco		Italy	23900
71	Fatebenefratelli and Ophthalmic Hospital	Milano		Italy	20121
72	Fondazione Ospedale Maggiore Policlinico - Mangiagalli e Regina Elena	Milano		Italy	20122
73	San Paolo Hospital	Milano		Italy	20142
74	San Carlo Borromeo Hospital	Milano		Italy	20153
75	Azienda Ospedaliera Luigi Sacco Polo Universitario	Milano		Italy	20157
76	A.O. Monaldi	Napoli		Italy	80131
77	Cardarelli Hospital	Napoli		Italy	80131
78	D. Cotugno Hospital	Napoli		Italy	80131
79	San Gennaro Hospital - ASL NA 1	Napoli		Italy	80136
80	Ospedale Maggiore della Carità	Novara		Italy	28100
81	Azienda Ospedaliera Universitaria Presidio "Paolo Giaccone"	Palermo		Italy	90127
82	Presidio Ospedaliero "M. Ascoli" ARNAS Civico	Palermo		Italy	90127
83	Centro Oncologico "La Maddalena"	Palermo		Italy	90146
84	S. Maria della Misericordia Hospital	Perugia		Italy	06156
85	Piacenza Hospital	Piacenza		Italy	29100
86	S. Maria degli Angeli Hospital	Pordenone		Italy	33170
87	Ospedale Civile Santa Maria delle Croci	Ravenna		Italy	48100
88	Arcispedale S. Maria Nuova	Reggio Emilia		Italy	42100
89	Ospedale San Pietro Fatebenefratelli	Roma		Italy	00100
90	Pneumologia Oncologica II-San Camillo Forlanini Hospital	Roma		Italy	00149
91	Oncologia Medica-San Camillo Forlanini Hopsital	Roma		Italy	00152
92	Università Campus Bio-Medico	Roma		Italy	00155
93	Policlinico Umberto I	Roma		Italy	00161
94	Policlinico Umberto I	Roma		Italy	00161
95	S. Giovanni - Addolorata Hospital	Roma		Italy	00184
96	Azienda Ospedaliera S. Giovanni di Dio e Ruggi d'Aragona	Salerno		Italy	84122
97	Ospedale Civile SS. Annunziata	Sassari		Italy	07100
98	Universita' di Sassari Oncologia Medica	Sassari		Italy	07100
99	Ospedale Morelli	Sondrio		Italy	23035
100	Sondrio Hospital-Azienda Ospedaliera Valtellina e Valchiavenna	Sondrio		Italy	23100
101	A.O.U. San Giovanni Battista Molinette	Torino		Italy	10134
102	Ospedale di Circolo	Varese		Italy	21100
103	SS. Giovanni e Paolo Hospital	Venezia		Italy	30122
104	San Bartolo Hospital	Vicenza		Italy	36100
105	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76.
• Armstrong BG, Sloan M. Ordinal regression models for epidemiologic data. Am J Epidemiol. 1989 Jan;129(1):191-204.
• Bell DW, Lynch TJ, Haserlat SM, Harris PL, Okimoto RA, Brannigan BW, Sgroi DC, Muir B, Riemenschneider MJ, Iacona RB, Krebs AD, Johnson DH, Giaccone G, Herbst RS, Manegold C, Fukuoka M, Kris MG, Baselga J, Ochs JS, Haber DA. Epidermal growth factor receptor mutations and gene amplification in non-small-cell lung cancer: molecular analysis of the IDEAL/INTACT gefitinib trials. J Clin Oncol. 2005 Nov 1;23(31):8081-92. Epub 2005 Oct 3.
• Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer. 1994;30A(5):635-42.
• Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczésna A, Juhász E, Esteban E, Molinier O, Brugger W, Melezínek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.
• Cappuzzo F, Hirsch FR, Rossi E, Bartolini S, Ceresoli GL, Bemis L, Haney J, Witta S, Danenberg K, Domenichini I, Ludovini V, Magrini E, Gregorc V, Doglioni C, Sidoni A, Tonato M, Franklin WA, Crino L, Bunn PA Jr, Varella-Garcia M. Epidermal growth factor receptor gene and protein and gefitinib sensitivity in non-small-cell lung cancer. J Natl Cancer Inst. 2005 May 4;97(9):643-55.
• Cappuzzo F, Magrini E, Ceresoli GL, Bartolini S, Rossi E, Ludovini V, Gregorc V, Ligorio C, Cancellieri A, Damiani S, Spreafico A, Paties CT, Lombardo L, Calandri C, Bellezza G, Tonato M, Crinò L. Akt phosphorylation and gefitinib efficacy in patients with advanced non-small-cell lung cancer. J Natl Cancer Inst. 2004 Aug 4;96(15):1133-41.
• Cappuzzo F, Varella-Garcia M, Shigematsu H, Domenichini I, Bartolini S, Ceresoli GL, Rossi E, Ludovini V, Gregorc V, Toschi L, Franklin WA, Crino L, Gazdar AF, Bunn PA Jr, Hirsch FR. Increased HER2 gene copy number is associated with response to gefitinib therapy in epidermal growth factor receptor-positive non-small-cell lung cancer patients. J Clin Oncol. 2005 Aug 1;23(22):5007-18.
• 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
• Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, Liao ML, Bischoff H, Reck M, Sellers MV, Watkins CL, Speake G, Armour AA, Kim ES. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol. 2010 Feb 10;28(5):744-52. doi: 10.1200/JCO.2009.24.3030. Epub 2009 Dec 28.
• Fukuoka M, Wu YL, Thongprasert S, Sunpaweravong P, Leong SS, Sriuranpong V, Chao TY, Nakagawa K, Chu DT, Saijo N, Duffield EL, Rukazenkov Y, Speake G, Jiang H, Armour AA, To KF, Yang JC, Mok TS. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol. 2011 Jul 20;29(21):2866-74. doi: 10.1200/JCO.2010.33.4235. Epub 2011 Jun 13.
• Gatzemeier U, Pluzanska A, Szczesna A, Kaukel E, Roubec J, De Rosa F, Milanowski J, Karnicka-Mlodkowski H, Pesek M, Serwatowski P, Ramlau R, Janaskova T, Vansteenkiste J, Strausz J, Manikhas GM, Von Pawel J. Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva Lung Cancer Investigation Trial. J Clin Oncol. 2007 Apr 20;25(12):1545-52.
• Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. Erratum in: CA Cancer J Clin 2001 Mar-Apr;51(2):144.
• Hanna N, Shepherd FA, Fossella FV, Pereira JR, De Marinis F, von Pawel J, Gatzemeier U, Tsao TC, Pless M, Muller T, Lim HL, Desch C, Szondy K, Gervais R, Shaharyar, Manegold C, Paul S, Paoletti P, Einhorn L, Bunn PA Jr. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol. 2004 May 1;22(9):1589-97.
• Herbst RS, Prager D, Hermann R, Fehrenbacher L, Johnson BE, Sandler A, Kris MG, Tran HT, Klein P, Li X, Ramies D, Johnson DH, Miller VA; TRIBUTE Investigator Group. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2005 Sep 1;23(25):5892-9. Epub 2005 Jul 25.
• Hirsch FR, Varella-Garcia M, Bunn PA Jr, Franklin WA, Dziadziuszko R, Thatcher N, Chang A, Parikh P, Pereira JR, Ciuleanu T, von Pawel J, Watkins C, Flannery A, Ellison G, Donald E, Knight L, Parums D, Botwood N, Holloway B. Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer. J Clin Oncol. 2006 Nov 1;24(31):5034-42.
• Horgan AM, Bradbury PA, Amir E, Ng R, Douillard JY, Kim ES, Shepherd FA, Leighl NB. An economic analysis of the INTEREST trial, a randomized trial of docetaxel versus gefitinib as second-/third-line therapy in advanced non-small-cell lung cancer. Ann Oncol. 2011 Aug;22(8):1805-11. doi: 10.1093/annonc/mdq682. Epub 2011 Jan 27.
• Keedy VL, Temin S, Somerfield MR, Beasley MB, Johnson DH, McShane LM, Milton DT, Strawn JR, Wakelee HA, Giaccone G. American Society of Clinical Oncology provisional clinical opinion: epidermal growth factor receptor (EGFR) Mutation testing for patients with advanced non-small-cell lung cancer considering first-line EGFR tyrosine kinase inhibitor therapy. J Clin Oncol. 2011 May 20;29(15):2121-7. doi: 10.1200/JCO.2010.31.8923. Epub 2011 Apr 11.
• Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008 Nov 22;372(9652):1809-18. doi: 10.1016/S0140-6736(08)61758-4.
• Lee DH, Park K, Kim JH, Lee JS, Shin SW, Kang JH, Ahn MJ, Ahn JS, Suh C, Kim SW. Randomized Phase III trial of gefitinib versus docetaxel in non-small cell lung cancer patients who have previously received platinum-based chemotherapy. Clin Cancer Res. 2010 Feb 15;16(4):1307-14. doi: 10.1158/1078-0432.CCR-09-1903. Epub 2010 Feb 9.
• Marchetti A, Martella C, Felicioni L, Barassi F, Salvatore S, Chella A, Camplese PP, Iarussi T, Mucilli F, Mezzetti A, Cuccurullo F, Sacco R, Buttitta F. EGFR mutations in non-small-cell lung cancer: analysis of a large series of cases and development of a rapid and sensitive method for diagnostic screening with potential implications on pharmacologic treatment. J Clin Oncol. 2005 Feb 1;23(4):857-65.
• Maruyama R, Nishiwaki Y, Tamura T, Yamamoto N, Tsuboi M, Nakagawa K, Shinkai T, Negoro S, Imamura F, Eguchi K, Takeda K, Inoue A, Tomii K, Harada M, Masuda N, Jiang H, Itoh Y, Ichinose Y, Saijo N, Fukuoka M. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol. 2008 Sep 10;26(26):4244-52. doi: 10.1200/JCO.2007.15.0185.
• Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.
• Osoba D, Bezjak A, Brundage M, Zee B, Tu D, Pater J; Quality of Life Committee of the NCIC CTG. Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer. 2005 Jan;41(2):280-7.
• Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8.
• Schuette W, Nagel S, Blankenburg T, Lautenschlaeger C, Hans K, Schmidt EW, Dittrich I, Schweisfurth H, von Weikersthal LF, Raghavachar A, Reissig A, Serke M. Phase III study of second-line chemotherapy for advanced non-small-cell lung cancer with weekly compared with 3-weekly docetaxel. J Clin Oncol. 2005 Nov 20;23(33):8389-95.
• Sequist LV, Joshi VA, Jänne PA, Muzikansky A, Fidias P, Meyerson M, Haber DA, Kucherlapati R, Johnson BE, Lynch TJ. Response to treatment and survival of patients with non-small cell lung cancer undergoing somatic EGFR mutation testing. Oncologist. 2007 Jan;12(1):90-8.
• Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol. 2000 May;18(10):2095-103.
• Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabárbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32.
• Taron M, Ichinose Y, Rosell R, Mok T, Massuti B, Zamora L, Mate JL, Manegold C, Ono M, Queralt C, Jahan T, Sanchez JJ, Sanchez-Ronco M, Hsue V, Jablons D, Sanchez JM, Moran T. Activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor are associated with improved survival in gefitinib-treated chemorefractory lung adenocarcinomas. Clin Cancer Res. 2005 Aug 15;11(16):5878-85.
• van Zandwijk N, Mathy A, Boerrigter L, Ruijter H, Tielen I, de Jong D, Baas P, Burgers S, Nederlof P. EGFR and KRAS mutations as criteria for treatment with tyrosine kinase inhibitors: retro- and prospective observations in non-small-cell lung cancer. Ann Oncol. 2007 Jan;18(1):99-103. doi: 10.1093/annonc/mdl323. Epub 2006 Oct 23.

• Responsible Party: Scanni Alberto, Alberto Scanni MD, Fatebenefratelli and Ophthalmic Hospital
• ClinicalTrials.gov Identifier: NCT00637910
• Other Study ID Numbers: FARM6F5JER; 2007-004786-17
• First Posted: Mar 18, 2008
• Last Update Posted: Feb 24, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Scanni Alberto, Alberto Scanni MD, 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; Docetaxel; Erlotinib Hydrochloride

Study Results

No Results Posted as of Feb 24, 2012