Table 1.
Antimicrotubule trials.
| Trial | N randomized/evaluable | Treatment arms (dose) and schedule | Duration |
| Tannock, 2004 [64] | 1006/1006 | docetaxel (75 mg/m2) iv q 3 wks prednisone (5 mg) po twice daily dexamethasone (8 mg) at 12, 3, and 1 hr(s) prior to infusion | 10 cycles |
| docetaxel (30 mg/m2) iv q wk for 5 wks prednisone (5 mg) po twice daily dexamethasone (8 mg) at 1 hr prior to infusion | 5 cycles | ||
| mitoxantrone (12 mg/m2) iv q 3 wks prednisone (5 mg) po twice daily | 10 cycles | ||
| Petrylak, 2004 [63] | 770/666 | docetaxel (60 mg/m2)* iv q 3 wks EMP (280 mg) po thrice daily q 3 wks dexamethasone (20 mg) po thrice daily q 3 wks | 12 cycles |
| mitoxantrone (12 mg/m2)* iv q 3 wks prednisone (5 mg) po twice daily q 3 wks | |||
| Abratt, 2003 [62] | 451/414 | vinorelbine (30 mg/m2) iv q 3 wks hydrocortisone (40 mg) ± AGM (1000 mg)† daily | to progression |
| hydrocortisone (40 mg) ± AGM (1000 mg)† daily | |||
| Berry, 2001 [84] | 166/NR | paclitaxel (100 mg/m2) iv q 4 wks EMP (280 mg) po thrice daily | NR |
| paclitaxel (100 mg/m2) iv q 4 wks | |||
| Hudes, 1999 [61] | 201/193 | vinblastine (4 mg/m2) iv q wk for 6 of 8 wks EMP (600 mg/m2) po daily (2 or 3 divided doses) | to progression |
| vinblastine (4 mg/m2) iv q wk for 6 of 8 wks | |||
| Iversen, 1997 [65] | 131/129 | EMP (560 mg) po daily (2 divided doses) | as long as tolerated by patient |
| placebo po daily | |||
| Johansson, 1991 [66] | 105/102 | MPA (1000 mg) im daily (d1-15), then im weekly | to progression |
| EMP (280 mg) po twice daily | |||
| De Kernion, 1988 [67] | 220/203 | EMP (600 mg/m2) po (3 divided doses) | NR |
| flutamide (0.25 gm) po thrice daily | |||
| Murphy, 1979 [68] | 135/116 | EMP (600 mg/m2) po daily (3 divided doses) prednimustine (30 mg) po daily (3 divided doses) q wk | to progression |
| prednimustine (30 mg) po daily (3 divided doses) q wk |
*Docetaxel could be increased to 70 mg/m2 and mitoxantrone could be increased to 14 mg/m2 if no grade 3 or 4 toxicities were observed in cycle 1; †decision to use AGM was at the discretion of participating centers.
Abbreviations: AGM – aminoglutethimide; d – day; EMP – estramustine phosphate; hr – hour; im – intra muscular; iv – intravenous; mg – milligrams; MPA – medroxyprogesterone acetate; m2 - meters squared; N – number; NR – not reported; po – per oral; q – every; wk(s) – week (s).