Table 8.
Trial | N randomized/evaluable | Treatments (dose) and schedule | Duration |
Carducci, 2004 [85] | 809/809 | atrasentan po (10 mg) | NR |
placebo | |||
Carducci, 2003 [79] | 288/288 | atrasentan (2.5 mg) po daily | to progression |
atrasentan (10 mg) po daily | |||
placebo | |||
Small, 2003 [86] | 127/127 | APC8015 iv q 2 wks × 3 | to progression |
placebo | |||
Small, 2002 [81] | 390/390 | suramin (3.192 mg/m2)* iv | 3 cycles (12 weeks) |
suramin (5.320 mg/m2)* iv | |||
suramin (7.661 mg/m2)* iv | |||
Ahmann, 2001 [87] | 553/406† | prinomastat (5 mg) po twice daily mitoxantrone (12 mg/m2) iv q 3 wks prednisone (5 mg) po twice daily | NR |
prinomastat (10 mg) po twice daily mitoxantrone (12 mg/m2) iv q 3 wks prednisone (5 mg) po twice daily | |||
mitoxantrone (12 mg/m2) iv q 3 wks prednisone (5 mg) po twice daily placebo | |||
Small, 2000 [82] | 460/458 | suramin d1: 1000 mg/m2 2-hr iv d2-5: 400 mg/m2, 300 mg/m2, 250 mg/m2, and 200 mg/m2 iv, respectively d8,11,15,19: 275 mg/m2 iv for 2 wks d22,29,36,43,50,57,64,71,78: 275 mg/m2 iv wks 4–12 hydrocortisone (40 mg) po daily | to progression or unacceptable toxicity |
hydrocortisone po daily placebo | |||
Debruyne, 1998 [83] | 321/321 | liarozole (300 mg) twice daily | to progression or unacceptable toxicity |
CPA (100 mg) twice daily |
*Doses of suramin decreased over 10 weeks; all patients received hydrocortisone at a dose of 25 mg orally each morning and 15 mg orally each evening; †interim results available for 406/553 patients.
Abbreviations: CPA – cyproterone acetate; d – day; DES – diethylstilbestrol diphosphate; g – grams; hr – hour; iv – intravenous; m2 - meters squared; mg – milligram; N – number; NR – not reported; po – per oral; q – every; wk(s) – week(s); × – times.