Table 2.
Detailed description of chemotherapy dosing and adverse events
| Patient | Cohort | Gemcitabine dose, mg/m2 | Sequencing | DLT | Severe adverse events (grade) |
|---|---|---|---|---|---|
| 1 | 1A | 50 | CG | No | Late ureteral stricture (3) |
| 2 | 1A | 50 | CG | No | - |
| 3 | 1A | 50 | CG | Yes | Acute nausea, emesis (3) |
| 4 | 1B | 50 | CG | No | - |
| 5 | 1B | 50 | CG | No | - |
| 7 | 1B | 50 | CG | No | - |
| 6 | EF-1A | 50 | CG | No | - |
| 13 | EF-1A | 50 | CG | Yes | Acute pulmonary embolism (4) |
| 17* | EF-1A | 50 | CG | Yes | Acute drug hypersensitivity (4) |
| 8† | 2A | 75 | CG | No | - |
| 9 | 2A | 75 | CG | Yes | Acute nausea, emesis (3) |
| Late ureteral stricture (3) | |||||
| 10 | 2A | 75 | CG | No | Late radiation cystitis (3) |
| 11 | 2B | 75 | CG | No | - |
| 12 | 2B | 75 | CG | No | - |
| 14‡ | 3A | 100 | CG | No | - |
| 15 | 3A | 100 | CG | No | - |
| 16 | 3A | 100 | CG | No | - |
| 18*,§ | 4A | 125 | CG | No | - |
| 19 | 4A | 125 | CG | No | - |
| 20 | 4A | 125 | CG | No | - |
| 26 | 6A | 75 | GC | No | - |
| 27 | 6A | 75 | GC | No | - |
| 28 | 6A | 75 | GC | No | - |
| 29*,§ | 6B | 75 | GC | No | - |
| 30|| | 6B | 75 | GC | No | - |
| 31¶ | 7A | 100 | GC | No | - |
| 32|| | 7A | 100 | GC | No | - |
| 33|| | 7A | 100 | GC | No | - |
| 34 | 7B | 100 | GC | Yes | Acute nausea, diarrhea (3) |
| 35|| | 7B | 100 | GC | No | - |
| 21 | 5A | 125 | GC | Yes | Acute thrombocytopenia (4) |
| 22 | 5A | 125 | GC | No | - |
| 23 | 5A | 125 | GC | No | - |
| 24 | 5B | 125 | GC | No | - |
| 25 | 5B | 125 | GC | Yes | Acute nausea, diarrhea (3) |
Abbreviations: CG = cisplatin followed by gemcitabine; EF = extended (paraortic) radiation field; GC = gemcitabine followed by cisplatin.
*
Received stereotactic boost.
†
Postoperative, residual disease.
‡
Patient assigned to cohort 3A inadvertently, so only 5 patients were enrolled in cohort 2.
§
Postoperative, recurrent disease.
||
Received interstitial brachytherapy boost.
¶
Cohort 7 was added after a protocol amendment was approved during the enrollment of cohort 6, so dose escalation proceeded after only 5 patients were enrolled to cohort 6. The trial was closed administratively after 5 patients were enrolled in cohort 7.