Characteristics* | Phase I (n = 14) | Phase II (n = 49) |
---|---|---|
Eligible | 14 (100%) | 45 (92%) |
Evaluable | 11 (79%) | 36 (73%) |
Median age (range) years | 59.0 (30.0–69.0) | 63.0 (37.0–71.0) |
Sex | ||
   Male | 7 (50%) | 33 (67%) |
   Female | 7 (50%) | 16 (33%) |
WHO performance status | ||
   0 | 4 (29%) | 14 (29%) |
   1 | 10 (71%) | 31 (63%) |
   2 | 0 | 4 (8%) |
Primary tumour site | ||
   Colon | 9 (64%) | 17 (35%) |
   Rectum | 4 (29%) | 22 (45%) |
   Colon rectosigmoid | 1 (7%) | 10 (20%) |
Organ involved | ||
   Median number | 2 (1–4) | 2 (1–4) |
   Liver | 10 (71%) | 42 (86%) |
   Lung | 6 (43%) | 17 (35%) |
   Lymph node | 1 (7%) | 10 (20%) |
   Other soft tissue | 0 | 11 (22%) |
   Abdominal cavity | 2 (14%) | 3 (6%) |
   Peritoneum | 1 (7%) | 0 |
   Bone | 1 (7%) | 0 |
   Skin | 0 | 1 (2%) |
   Other | 2 (14%) | 5 (10%) |
Prior therapy | ||
   Surgery | 12 (86%) | 42 (86%) |
   Radiotherapy | 3 (21%) | 14 (29%) |
   Adjuvant chemotherapy | 4 (29%) | 12 (24%) |
   Surgery + radiotherapy | 3 (21%) | 12 (24%) |
   Surgery + chemotherapy | 4 (29%) | 12 (24%) |
   Radiotherapy + chemotherapy | 2 (14%) | 7 (14%) |
   Surgery + radiotherapy + chemotherapy | 2 (14%) | 7 (14%) |