Table 9

Phase II and III clinical studies with L-DOX

Cancer^9-a	Liposome Formulation^9-b	Dose	Schedule	Total Responses	Complete Response	Response Duration
		mg/m²		%		days
Kaposi's sarcoma (n = 16)^9-e	Doxil	20	×3 wk	75		98
Kaposi's sarcoma (n = 24)^9-f(patients failed standard chemotherapy)	DaunoXome	40	×2 wk	54.2	8.3	84
Kaposi's sarcoma (n = 22)^9-g	DaunoXome	50–60	×2 wk	55	5
Kaposi's sarcoma (n = 34)^9-h	Doxil	20	×3 wk	73.5	5.8	63
Kaposi's sarcoma (n = 29)^9-i	Free DOX	20	×2 wk	48	3	105
Kaposi's sarcoma (n = 116)^9-j	DaunoXome	40	×2 wk	25	2.5	175
	ABV	10, 15 U, 1 mg	×2 wk	28	0.9	168
Kaposi's sarcoma (n = 30)^9-k	DaunoXome	40	×2 wk	73		153
Kaposi's sarcoma (n = 29)^9-l	DaunoXome	40	×2 wk	45		70
Kaposi's sarcoma (n = 53)^9-m(patients failed standard chemotherapy)	Doxil	20	×3 wk	36	1.8	128
Ovarian carcinoma (n = 35)^9-c ^9-n	Doxil	40–50	×3 wk	25.7	2.9	180
Metastatic breast carcinoma (n = 64)^9-o	Doxil	45–60	3–4 wk	31	6.3	270
Kaposi's sarcoma (n = 40)^9-p	Doxil	20	×3 wk	70
Kaposi's sarcoma (n = 121)^9-q	Doxil	20	×3 wk	58.7	5.8	160.4
	BV	15 IU/m², 2 mg	×3 wk	23.3	0.8	156.7
Kaposi's sarcoma (n = 133)^9-r	Doxil	20	×2 wk	45.9	0.8	90
	ABV	20, 10, 1 mg	×2 wk	24.8		92
Metastatic breast carcinoma (n = 69)^9-s	TLC D-99	75	×3 wk	33	3
	Free DOX	75	×3 wk	28	1
Metastatic breast carcinoma (n = 69)^9-t	TLC D-99/CPA/5-FU^9-e	60, 500, 500	×3 wk^9-d	68	5

CPA, cyclophosphamide; 5-FU, 5-fluorouracil.
↵9-a Values are number of accessable patients.
↵9-b The composition, size, and drug/lipid ratio for DaunoXome and Doxil are listed in Table 1.
↵9-c Patients failed to respond to platinum- and paclitaxel-based regimens.
↵9-d Both CPA and TLC D-99 were administered on day 1, and 5-FU was administered on days 1 and 8.
↵9-e Simpson et al. (1993).
↵9-f Presant et al. (1993).
↵9-g Gill et al. (1995).
↵9-h Harrison et al. (1995).
↵9-i Gill et al. (1991).
↵9-j Gill et al. (1996).
↵9-k Girard et al. (1996).
↵9-l Uthayakumar et al. (1996).
↵9-m Northfelt et al. (1997).
↵9-n Muggia et al. (1997).
↵9-o Ranson et al. (1997).
↵9-p Amantea et al. (1997).
↵9-q Stewart et al. (1998).
↵9-r Northfelt et al. (1998).
↵9-s Harris et al. (1998).
↵9-t Valero et al. (1999).