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

Abstract 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, a...

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Veröffentlicht in:	Clinical lung cancer 2007-11, Vol.8 (9), p.568-571
Hauptverfasser:	Gridelli, Cesare, Rossi, Antonio, Morgillo, Floriana, Bareschino, Maria Anna, Maione, Paolo, Di Maio, Massimo, Ciardiello, Fortunato
Format:	Artikel
Sprache:	eng
Schlagworte:	Age Factors Aged Aged, 80 and over Antimetabolites, Antineoplastic - administration & dosage Antimetabolites, Antineoplastic - adverse effects Antineoplastic Combined Chemotherapy Protocols - adverse effects Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - pathology Carcinoma, Non-Small-Cell Lung - physiopathology Chemotherapy Disease-Free Survival Everolimus Female Glutamates - administration & dosage Glutamates - adverse effects Guanine - administration & dosage Guanine - adverse effects Guanine - analogs & derivatives Hematology, Oncology and Palliative Medicine Humans Immunosuppressive Agents Lung Neoplasms - drug therapy Lung Neoplasms - pathology Lung Neoplasms - physiopathology Male Mammalian target of rapamycin Neoplasm Staging Pemetrexed Pulmonary/Respiratory Sirolimus - administration & dosage Sirolimus - adverse effects Sirolimus - analogs & derivatives Targeted therapy
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Zusammenfassung:	Abstract 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.
ISSN:	1525-7304 1938-0690
DOI:	10.3816/CLC.2007.n.045