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

March 12, 2008
February 23, 2012
November 2007
February 2012   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 12 months after the last patient is randomized ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00637910 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Tarceva Italian Lung Optimization tRial
Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer (NSCLC)
  • Drug: Erlotinib
    Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops
    Other Name: Tarceva
  • 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
  • Experimental: Erlotinib Arm
    Intervention: Drug: Erlotinib
  • Active Comparator: Docetaxel Arm
    Intervention: Drug: Docetaxel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
850
February 2013
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Marina C Garassino, MD +39 0263632223 marina.garassino@fbf.milano.it
Contact: Serena Girelli, Biologist +39 0263632223 datamanager@fbf.milano.it
Italy
 
NCT00637910
FARM6F5JER, 2007-004786-17
Yes
Scanni Alberto, Fatebenefratelli and Ophthalmic Hospital
Fatebenefratelli and Ophthalmic Hospital
  • Mario Negri Institute for Pharmacological Research
  • Niguarda Hospital
Principal Investigator: Alberto Scanni, MD Fatebenefratelli and Ophthalmic Hospital
Fatebenefratelli and Ophthalmic Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP