Tarceva Italian Lung Optimization tRial (TAILOR)
|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
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer (NSCLC)||Drug: Erlotinib Drug: Docetaxel||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||850 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Erlotinib Arm||
Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops
Other Name: Tarceva
|Active Comparator: Docetaxel Arm||
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
- Overall Survival [ Time Frame: 12 months after the last patient is randomized ]
- Progression Free Survival [ Time Frame: with 4 years and 12 months after the last patient is randomized ]
- Response assessed with RECIST criteria [ Time Frame: within 4 years ]
- Quality of Life assessed with QLQ-C30 and QLQ-LC13 questionnaires [ Time Frame: within 4 years ]
- Toxicity, graded according to the NCI-CTAE version 3.0 [ Time Frame: within 4 years ]
- Frequency and nature of serious adverse reactions [ Time Frame: within 4 years ]
- Premature withdrawals [ Time Frame: within 4 years ]
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
|Contact: Marina C Garassino, MD||+39 email@example.com|
|Contact: Serena Girelli, Biologist||+39 firstname.lastname@example.org|
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|Principal Investigator:||Alberto Scanni, MD||Fatebenefratelli and Ophthalmic Hospital|