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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborators:
Mario Negri Institute for Pharmacological Research
Niguarda Hospital
Information provided by (Responsible Party):
Scanni Alberto, Fatebenefratelli and Ophthalmic Hospital

Study Description
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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
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00637910


Contacts
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Contact: Marina C Garassino, MD +39 0263632223 marina.garassino@fbf.milano.it
Contact: Serena Girelli, Biologist +39 0263632223 datamanager@fbf.milano.it

Locations
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Sponsors and Collaborators
Fatebenefratelli and Ophthalmic Hospital
Mario Negri Institute for Pharmacological Research
Niguarda Hospital
Investigators
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Principal Investigator: Alberto Scanni, MD Fatebenefratelli and Ophthalmic Hospital
More Information
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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):

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Responsible Party: Scanni Alberto, Alberto Scanni MD, Fatebenefratelli and Ophthalmic Hospital
ClinicalTrials.gov Identifier: NCT00637910    
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
EGFR copy number
Kras mutations
 EGRF mutations
Docetaxel
Erlotinib
Polymorphisms
Additional relevant MeSH terms:
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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
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors