Clinical Trials with Pegylated Liposomal Doxorubicin in the Treatment of Ovarian Cancer

Table 3

Phase-I-II-III studies with pegylated liposomal doxorubicin (PLD) in combination with target agents.

Author	Dose/schedule	Clinical setting; PFI (mts)	No. pts	RR (%)	PFS (median); (mts)
Muggia et al. [55]	PLD 30 mg/m and; BEV 15 mg/kg on cycles 2–7 (with option to continue)	≤6	48	Ongoing	Ongoing
Pujade-Lauraine et al. [56]	Arm1; PTX (80 mg/m^2) d1, 8, 15 and 22 q28; or; TPT (4 mg/m^2) d1, 8, 15 q28; or; PLD (40 mg/m^2) d1 q28	≤6	166	12.6	3.4
	Arm2; BEV 10 m/kg d1 q15 or 15 mg/kg d1 q21,; PTX (80 mg/m^2) d1, 8, 15 and 22 q28; or; TPT (4 mg/m^2) d1, 8, 15 q28; or; PLD (40 mg/m^2) d1 q28		135	30.9	6.7
Del Carmen et al. [57]	PLD (30 mg/m^2) d1 q28,; CBDCA (AUC5) d1 q28, Beva 10 mg/kg d1 q14	≥6	54	72.2	13.9
Steffensen et al. [58]	PAN 6 mg/kg d1, 15 q28/PLD 40 mg/m² day 1 q28	≤6	46	24.3	2.7–8.1
TRINOVA 2 [59] http://clinicaltrials.gov/show/NCT01281254	Arm 1; PLD 50 mg/m² d1 q28 and blinded AMG 386 15 mg/kg qw; Arm 2; PLD 50 mg/m² d1 q28 and blinded AMG 386/placebo qw	≤12	Ongoing	Ongoing	Ongoing
Boers-Sonderen et al. [60]	T 15–20 mg/m²/PLD 20–40 mg/mq	ALL	20	3PR; 9SD	4.9

PFS: progression-free survival; PTX: paclitaxel; TPT: topotecan; T: temsirolimus; PAN: panitumumab; BEV: bevacizumab; RR: response rate; SEN: platinum-sensitive recurrentdisease; TRAB: trabectedin; q: every; d: day. *Statistically significant.