Table 2.

Dose Escalation and DLT of Increased Irinotecan Doses in Patients Treated With FOLFIRI

Irinotecan Dose (mg/m2)	No. of *1/*1 Patients	DLT		No. of *1/*28 Patients	DLT
		No. of Patients With DLT	Type of DLT		No. of Patients With DLT	Type of DLT
215	4*	0		6	1	Grade 3 nausea, diarrhea, anorexia, and asthenia
260	12†	1	Grade 4 thrombocytopenia, grade 3 diarrhea	4‡	0
310	6	1	Grade 3 stomatitis, grade 4 pancytopenia§	10	0
370	10	0		4	2	Grade 4 neutropenia and leucopenia, grade 3 asthenia
420	3	2	Grade 3 anorexia, grade 4 asthenia, grade 3 diarrhea	—

Abbreviations: DLT, dose-limiting toxicity; FOLFIRI, infusional fluorouracil and leucovorin plus irinotecan.

^*One “excess patient” (see Discussion for the definition of excess patients).

^†Six excess patients.

^‡One excess patient.

^§One toxic death (grade 5).