Overall and per-treatment-group patient baseline characteristics
| Baseline characteristics | Overall no. of patients (%) | Arm A (%) | Arm B (%) | Arm C (%) |
|---|---|---|---|---|
| Total | 19 | 5 | 8 | 6 |
| Age | ||||
| Median | 60 | 51 | 57.5 | 61.5 |
| Range | 27–86 | 27–71 | 50–86 | 47–77 |
| Sex | ||||
| Male | 6 (32) | 1 (20) | 4 (50) | 1 (17) |
| Female | 13 (68) | 4 (80) | 4 (50) | 5 (83) |
| ECOG Performance Status | ||||
| 0 | 10 | 2 | 4 | 4 |
| 1 | 9 | 3 | 4 | 2 |
| Stage at Trial Entry | ||||
| No evidence of disease | 4 (21) | 2 (40) | 0 (0) | 2 (33) |
| Locally advanced | 1 (5) | 0 (0) | 0 (0) | 1 (17) |
| Metastatic* | 14 (74) | 3 (60) | 8 (100) | 3 (50) |
| Prior Therapy | ||||
| Chemotherapy alone | 5 | 1 | 3 | 1 |
| Chemotherapy/RT alone | 2 | 0 | 1 | 1 |
| Surgery total | 12 | 4 | 4 | 4 |
| Surgery followed by chemotherapy | 7 | 3 | 2 | 2 |
| 5 | 1 | 2 | 2 | |
| Surgery followed by chemo/RT | ||||
| Prior surgical resection | ||||
| Yes | 12 (63) | 4 (80) | 4 (50) | 4 (67) |
| No | 7 (37) | 1 (20) | 4 (50) | 2 (33) |
| Serum CEA at trial initiation (ng/mL) | ||||
| Median | 4.8 | 5.3 | 4.65 | 7.95 |
| Range | 1–246.7 | 1.1–34.2 | 2.1–246.7 | 1–18.1 |
| Serum CA-19-9 at trial initiation (ng/mL) | ||||
| Median | 532 | 22 | 1067 | 27 |
| Range | 3–96,900 | 3–2,710 | 3–96,900 | 3–30,300 |
Abbreviation: Chemo/RT = chemotherapy in combination with radiation;
* All received previous chemotherapy.