Phase I study of carboplatin (C), pegylated liposomal doxorubicin (PLD) and everolimus (E) in platinum-sensitive epithelial ovarian, Fallopian tube or primary peritoneal cancer in first relapse (NCT01281514).

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 5580-5580
Author(s):  
Lainie P. Martin ◽  
Angela Jain ◽  
Christina Chu ◽  
Gina Mantia-Smaldone ◽  
Stephen C. Rubin ◽  
...  
2006 ◽  
Vol 12 (18) ◽  
pp. 5503-5510 ◽  
Author(s):  
Paul Sabbatini ◽  
Jakob Dupont ◽  
Carol Aghajanian ◽  
Felicia Derosa ◽  
Elizabeth Poynor ◽  
...  

2012 ◽  
Vol 30 (31) ◽  
pp. 3841-3847 ◽  
Author(s):  
Nicoletta Colombo ◽  
Elzbieta Kutarska ◽  
Meletios Dimopoulos ◽  
Duk-Soo Bae ◽  
Izabella Rzepka-Gorska ◽  
...  

Purpose This study compared the efficacy and safety of patupilone with those of pegylated liposomal doxorubicin (PLD) in patients with platinum-refractory or -resistant epithelial ovarian, primary fallopian tube, or primary peritoneal cancer. Patients and Methods Patients with three or fewer prior regimens were eligible if they had received first-line taxane/platinum-based combination chemotherapy and were platinum refractory or resistant. Patients were randomly assigned to receive patupilone (10 mg/m2 intravenously every 3 weeks) or PLD (50 mg/m2 intravenously every 4 weeks). Results A total of 829 patients were randomly assigned (patupilone, n = 412; PLD, n = 417). There was no statistically significant difference in overall survival (OS), the primary end point, between the patupilone and PLD arms (P = .195; hazard ratio, 0.93; 95% CI, 0.79 to 1.09), with median OS rates of 13.2 and 12.7 months, respectively. Median progression-free survival was 3.7 months for both arms. The overall response rate (all partial responses) was higher in the patupilone arm than in the PLD arm (15.5% v 7.9%; odds ratio, 2.11; 95% CI, 1.36 to 3.29), although disease control rates were similar (59.5% v 56.3%, respectively). Frequently observed adverse events (AEs) of any grade included diarrhea (85.3%) and peripheral neuropathy (39.3%) in the patupilone arm and mucositis/stomatitis (43%) and hand-foot syndrome (41.8%) in the PLD arm. Conclusion Patupilone did not demonstrate significant improvement in OS compared with the active control, PLD. No new or unexpected serious AEs were identified.


2007 ◽  
Vol 13 (13) ◽  
pp. 4026.1-4026
Author(s):  
Birgit C. Schultes ◽  
L. Mary Smith ◽  
Christopher F. Nicodemus

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