A randomized phase II study of pemetrexed or RAD001 as second-line treatment of advanced non-small-cell lung cancer in elderly patients: treatment rationale and protocol dynamics.
In the current clinical trial summary, we present a randomized phase II trial of pemetrexed or RAD001 as second-line treatment of elderly patients with advanced non-small-cell lung cancer. The molecular and clinical rationale is reviewed. The primary endpoint is progression-free survival, and secondary endpoints include objective tumor response rates, disease control rates, safety, tolerability, and overall survival. Based on the statistical design, the investigators plan to enroll 92 elderly patients, 46 per arm.
Gridelli
Cesare
C
Division of Medical Oncology, S.G. Moscati Hospital, Città Ospedaliera, Contrada Amoretta, Avellino, Italy. cgridelli@libero.it
Rossi
Antonio
A
Morgillo
Floriana
F
Bareschino
Maria Anna
MA
Maione
Paolo
P
Di Maio
Massimo
M
Ciardiello
Fortunato
F
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology* / Q000503:physiopathology; D018572:Disease-Free Survival; D000068338:Everolimus; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D007166:Immunosuppressive Agents; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000503:physiopathology; D008297:Male; D009367:Neoplasm Staging; D000068437:Pemetrexed; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
D000964:Antimetabolites, Antineoplastic; D005971:Glutamates; D007166:Immunosuppressive Agents; D000068437:Pemetrexed; D006147:Guanine; D000068338:Everolimus; D020123:Sirolimus