Tarceva Italian Lung Optimization tRial (TAILOR)

The recruitment status of this study is unknown because the information has not been verified recently.
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
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

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

  Show 105 Study Locations
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

Additional 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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014