Randomized Multicenter Phase II Study of Gemcitabine Versus Docetaxel as First-Line Therapy with Second-Line Crossover in Advanced-Stage Non–Small-Cell Lung Cancer

2005 ◽  
Vol 7 (3) ◽  
pp. 208-214 ◽  
Author(s):  
Christian Manegold ◽  
Lothar Richard Pilz ◽  
Gabriele Koschel ◽  
Katrin Schott-von Römer ◽  
Jörg Mezger ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase Ii Study ◽  
Small Cell ◽  
Advanced Stage ◽  
Second Line ◽  
Small Cell Lung ◽  
First Line ◽  
First Line Therapy ◽  
Multicenter Phase ◽  
Line Therapy

Phase II Study of Amrubicin As Second-Line Therapy in Patients With Platinum-Refractory Small-Cell Lung Cancer

2010 ◽  
Vol 28 (15) ◽  
pp. 2598-2603 ◽  
Author(s):  
David S. Ettinger ◽  
Robert Jotte ◽  
Paul Lorigan ◽  
Vicram Gupta ◽  
Lawrence Garbo ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase Ii Study ◽  
Small Cell ◽  
Second Line ◽  
Small Cell Lung ◽  
First Line ◽  
Second Line Therapy ◽  
First Line Therapy ◽  
Line Therapy ◽  
Platinum Refractory

Purpose Amrubicin is a synthetic anthracycline with potent topoisomerase II inhibition. This phase II study was conducted to confirm safety and activity of amrubicin in the treatment of refractory small-cell lung cancer (SCLC). Patients and Methods Patients with refractory SCLC (either with progressive disease as best response or progression within 90 days of first-line therapy) received amrubicin (40 mg/m2/d for 3 every 21 days). The primary end point was overall response rate (ORR); secondary end points included progression-free survival (PFS), overall survival (OS), and change in left ventricular ejection fraction (LVEF). Results Seventy-five patients with a median progression-free interval after first-line therapy of 38 days were enrolled; 69 patients received a median of four amrubicin cycles (range, one to 12 cycles). The ORR was 21.3% (95% CI, 12.7% to 32.3%), with one complete response (1.3%) and 15 partial responses (20%). Median PFS and OS were 3.2 months (95% CI, 2.4 to 4.0 months) and 6.0 months (95% CI, 4.8 to 7.1 months), respectively. The ORR in 43 patients who never responded to first-line therapy was 16.3% (95% CI, 6.8% to 30.7%). Most commonly reported grade 3 or 4 adverse events included neutropenia (67%), thrombocytopenia (41%), and anemia (30%), with febrile neutropenia in 12%. There was no decrease in mean LVEF with cumulative amrubicin doses exceeding 750 mg/m2. Conclusion Single-agent amrubicin showed promising activity with a 21.3% ORR and an acceptable safety profile when used as second-line therapy patients with platinum-refractory SCLC. Amrubicin did not induce early cardiotoxicity, but its long-term effects are unknown.

Phase II Study of Irinotecan Plus Cisplatin as First Line therapy in Extensive Small-Cell Lung Cancer

2006 ◽  
Vol 61 (2) ◽  
pp. 143
Author(s):  
Ki Eun Hwang ◽  
So Young Kim ◽  
Jong Hoon Jung ◽  
Seong Hoon Park ◽  
Jung Hyun Park ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Phase Ii Study ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy
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