Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition of erlotinib to chemotherapy has not achieved better results in the general population. However, several preclinical and phase I studies have shown that a sequential treatment of erlotinib and chemotherapy could avoid a possible negative interaction between both drugs when administrated concomitantly, and therefore, it could improve the benefit of the combination therapy. This study will investigate if the intermittent treatment of a chemotherapy drug, such as docetaxel, with erlotinib could achieve a clinical benefit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Docetaxel (Taxotere®) 75 mg/m2 iv first day of each 21-day cycle. Erlotinib (Tarceva®) 150 mg po days 2-16 of each 21-day cycle. Total: 4 cycles in the absence of disease progression
150 mg/day po daily
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
RECRUITINGHospital San Juan de Alicante
Alicante, Alicante, Spain
RECRUITINGHospital Clínica de Benidorm
Benidorm, Alicante, Spain
RECRUITINGHospital General de Elda
Elda, Alicante, Spain
NOT_YET_RECRUITINGHospital Provincial de Castellón
Castellon, Castellón, Spain
RECRUITINGHospital de Sagunto
Sagunto, Valencia, Spain
RECRUITINGHospital Arnau de Vilanova
Valencia, Valencia, Spain
RECRUITINGHospital Universitario Dr. Peset
Valencia, Valencia, Spain
RECRUITINGPercentage of patients without disease progression after 6 months of treatment.
Time frame: 6 months
Progression-free survival
Time frame: Time from randomization until objective tumor progression or death for any cause. Tumour progression will be assessed every 2 months.
Duration of Response
Time frame: The time from the first complete response or partial response until objective tumor progression or death due to progression disease. Tumour progression will be assessed every 2 months.
Overall Response Rate
Time frame: The proportion of patients with tumor size reduction (complete response or partial response following RECIST criteria). Response will be assessed every 2 months.
Disease Control Rate
Time frame: The proportion of patients without tumor size increase (complete response, partial response or stable disease following RECIST criteria). Response wil be assessed every 2 months.
Overall survival
Time frame: Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment.
Safety profile
Time frame: Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.