A dose escalation study of docetaxel plus capecitabine in combination with oxaliplatin in patients with advanced solid tumors

Figures & data

Table I. Patients' characteristics.

Patients enrolled	21
Median age (range)	68 (44–75)
Gender
Male/female	15/6
Performance status (WHO)
0	17 (80%)
1	4 (20%)
Tumor types
Pancreatic cancer	4
Renal cancer	4
Gastric cancer	9
Soft tissue sarcoma	1
Colorectal cancer	1
Unknown primary site	1
Hepatocellularcancer	1
Previous chemotherapy regimens
None	12
1	6
2 or more	3

Table II. Dose levels examined (mg/m²).

Level	No Patients	Docetaxel mg/m^2	Capecitabine mg/m^2	Oxaliplatin mg/m^2
I	3	50	2 000	70
II	3	50	2 250	70
III	3	50	2 250	75
IV	3	50	2 500	75
V	6	50	2 750	75
VI	3	50	2 750	80

Table III. Planned and administered doses (mg/m²/week) per patient and dose level.

Patient	Level	Taxotere (mg/m^2/week)		Oxaliplatin (mg/m^2/week)		Capecitabine (mg/m^2/week)		DLT
		Planned	Admin.	Planned	Admin.	Planned	Admin.
1	I	25	25	35	35	1000	1000	-
2	I	25	21	35	29	1000	840	-
3	I	25	21	35	30	1000	850	-
4	II	25	21	35	33	1125	1057	-
5	II	25	25	35	32	1125	1060	-
6	II	25	19	35	33	1125	1068	-
7	III	25	25	37.5	37.5	1125	1125	-
8	III	25	23	37.5	35	1125	1046	-
9	III	25	25	37.5	37.5	1125	1050	-
10	IV	25	22	37.5	37.5	1250	1250	-
11	IV	25	25	37.5	31	1250	1250	-
12	IV	25	25	37.5	37.5	1250	1250	-
13	V	25	20	37.5	30	1375	1100	-
14	V	25	22	37.5	33	1375	1196	-
15	V	25	17	37.5	25	1375	921	-
16	V	25	21	37.5	32	1375	1168	-
17	V	25	20	37.5	34.5	1375	1265	-
18	V	25	25	37.5	33	1375	1375	-
19	VI	25	20	40	37	1375	1265	Gr 3 diarrhea and asthenia (1pt)
20	VI	25	25	40	40	1375	1375	-
21	VI	25	25	40	40	1375	1375	Gr 3 diarrhea (1pt)

Table IV. Hematologic toxicity per cycle and dose-level (n = 121).

Level	No pts.	Cycles	Neutropenia		Anemia		Thrombocytopenia
			Gr 1/2	Gr 3	Gr 1/2	Gr 3	Gr 1/2	Gr 3
I	3	30	1 (3%)	3 (10%)	-	-	-	-
II	3	19	6 (31%)	1 (5%)	-	-	-	-
III	3	15	-	1 (7%)	2 (13%)	-	-	1 (7%)
IV	3	13	-	-	-	-	1 (8%)	-
V	6	35	7 (20%)	1 (3%)	4 (11%)	-	-	-
VI	3	9	3 (33%)	-	-	-	-	-
Total	21	121	17 (14%)	6 (5%)	6 (5%)	-	1 (1%)	1 (1%)

Table V. Non-hematologic toxicity per patient and dose-level (n = 21).

Level	Pts	Nausea		Diarrhea		Asthenia		Mucositis		PPE		Neuropathy
		Gr 1/2	Gr 3	Gr 1/2	Gr 3	Gr 1/2	Gr 3	Gr 1/2	Gr 3	Gr 1/2	Gr 3	Gr 1/2	Gr 3
I	3	1 (33%)	-	-	-	2 (66%)	-	1 (33%)	-	3 (100%)	-	1 (33%)	1 (33%)
II	3	-	-	-	-	-	-	1 (33%)	-	-	-	2 (66%)	-
III	3	-	-	1 (33%)		1 (33%)	1 (33%)	1 (33%)	-	-	-	2 (66%)	-
IV	3	1 (33%)	-	-	1 (33%)	-	-	1 (33%)	-	-	-		-
V	6	4 (67%)	-	2 (33%)	1 (17%)	1 (17%)	1 (17%)		-	-	-	2 (33%)	-
VI	3	-	-	-	2 (67%)	-	1 (33%)		-	-	-		-
Total	21	6 (29%)	-	3 (14%)	4 (19%)	4 (19%)	3 (14%)	4 (19%)	-	3 (14%)	-	7 (33%)	1 (5%)