A randomized phase II study of sorafenib/gemcitabine or sorafenib/erlotinib for advanced non-small-cell lung cancer in elderly patients or patients with a performance status of 2: treatment rationale and protocol dynamics.
Herein, we present a randomized phase II trial enrolling elderly patients or patients with a performance status (PS) of 2 affected by advanced non-small-cell lung cancer to receive, as first-line therapy, sorafenib/gemcitabine or sorafenib/erlotinib. The primary objective is 1-year survival, and secondary objectives include activity, toxicity, and overall survival. An additional secondary objective will be to evaluate biomarkers. Sample size is calculated on the basis of theory of selection. The study will enroll 100 patients: 58 patients aged >or= 70 years with a PS of 0-2 and 42 patients aged < 70 years with a PS of 2. The analysis will be conducted differently for the 2 groups of patients.
Gridelli
Cesare
C
Division of Medical Oncology, S.G. Moscati Hospital, Avellino, Italy. cgridelli@libero.it
Rossi
Antonio
A
Mongillo
Floriana
F
Bareschino
Maria
M
Maione
Paolo
P
Ciardiello
Fortunato
F
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D000069347:Erlotinib Hydrochloride; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008207:Lymphatic Metastasis / Q000517:prevention & control; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000008:administration & dosage; D011799:Quinazolines / Q000008:administration & dosage; D040262:Receptors, Vascular Endothelial Growth Factor / Q000037:antagonists & inhibitors; D000077157:Sorafenib; D015996:Survival Rate; D000093542:Gemcitabine
D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D011799:Quinazolines; D003841:Deoxycytidine; D009536:Niacinamide; D000077157:Sorafenib; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors; D040262:Receptors, Vascular Endothelial Growth Factor; D000093542:Gemcitabine