20707
document
Multi-institutional randomized phase II trial of the epothilone B analog ixabepilone ( BMS-247550 ) with or without estramustine phosphate in patients with progressive castrate metastatic prostate cancer . PURPOSE To evaluate the antitumor activity and safety of the epothilone B analog , ixabepilone , with or without estramustine phosphate ( EMP ) , in chemotherapy-naive patients with progressive castrate metastatic prostate cancer . PATIENTS AND METHODS Patients were randomly assigned to receive ixabepilone ( 35 mg/m ( 2 ) ) by intravenous infusion every 3 weeks with or without EMP 280 mg orally three times daily on days 1 to 5 . RESULTS Between December 2001 and October 2003 , 92 patients were enrolled and randomly assigned to treatment with ixabepilone alone ( 45 patients ) or in combination with EMP ( 47 patients ) . Grades 3 and 4 toxicities experienced by more than 5 % of patients included neutropenia ( 22 % ) , fatigue ( 9 % ) , and neuropathy ( 13 % ) on the ixabepilone arm , and neutropenia ( 29 % ) , febrile neutropenia ( 9 % ) , fatigue ( 9 % ) , neuropathy ( 7 % ) , and thrombosis ( 6 % ) on the ixabepilone + EMP arm . Post-treatment declines in prostate-specific antigen of > or = 50 % were achieved in 21 of 44 patients ( 48 % ; 95 % CI , 33 % to 64 % ) on the ixabepilone arm , and 31 of 45 patients ( 69 % ; 95 % CI , 55 % to 82 % ) on the ixabepilone + EMP arm . In patients with measurable disease , partial responses were observed in eight of 25 patients ( 32 % ; 95 % CI , 14 % to 50 % ) on the ixabepilone arm , and 11 of 23 ( 48 % ; 95 % CI , 27 % to 68 % ) on the ixabepilone + EMP arm . Time to prostate-specific antigen progression was 4.4 months ( 95 % CI , 3.1 to 6.9 months ) on the ixabepilone-alone arm and 5.2 months ( 95 % CI , 4.5 to 6.8 months ) on the combination arm . CONCLUSION Ixabepilone , with or without estramustine phosphate , is well tolerated and has antitumor activity in patients with castrate metastatic prostate cancer .
20708
Intervention_Pharmacological
epothilone B analog , ixabepilone , with or without estramustine phosphate ( EMP )
20709
Intervention_Pharmacological
ixabepilone
20710
Intervention_Pharmacological
EMP
20711
Intervention_Pharmacological
ixabepilone alone
20712
Intervention_Pharmacological
combination with EMP
20713
Intervention_Pharmacological
Ixabepilone
20714
Intervention_Pharmacological
estramustine phosphate
20715
Outcome_Physical
antitumor activity
20716
Outcome_Other
safety
20717
Outcome_Adverse-effects
Grades 3 and 4 toxicities
20718
Outcome_Adverse-effects
neutropenia
20719
Outcome_Adverse-effects
fatigue
20720
Outcome_Adverse-effects
neuropathy
20721
Outcome_Physical
neutropenia
20722
Outcome_Adverse-effects
febrile neutropenia
20723
Outcome_Adverse-effects
fatigue
20724
Outcome_Adverse-effects
neuropathy
20725
Outcome_Adverse-effects
thrombosis
20726
Outcome_Physical
prostate-specific antigen
20727
Outcome_Physical
partial responses
20728
Outcome_Other
Time to prostate-specific antigen progression
20729
Outcome_Other
tolerated
20730
Outcome_Other
antitumor activity