15758
document
Randomized Phase II trial assessing estramustine and vinblastine combination chemotherapy vs estramustine alone in patients with progressive hormone-escaped metastatic prostate cancer . Based on the results of combined data from three North American Phase II studies , a randomised Phase II study in the same patient population was performed , using combination chemotherapy with estramustine phosphate ( EMP ) and vinblastine ( VBL ) in hormone refractory prostate cancer patients . In all , 92 patients were randomised into a Phase II study of oral EMP ( 10 mg kg day continuously ) or oral EMP in combination with intravenous VBL ( 4 mg m ( 2 ) week for 6 weeks , followed by 2 weeks rest ) . The end points were toxicity and PSA response in both groups , with the option to continue the trial as a Phase III study with time to progression and survival as end points , if sufficient responses were observed . Toxicity was unexpectedly high in both treatment arms and led to treatment withdrawal or refusal in 49 % of all patients , predominantly already during the first treatment cycle . The mean treatment duration was 10 and 14 weeks , median time to PSA progression was 27.2 and 30.8 weeks , median survival time was 44 and 50.9 weeks , and PSA response rate was only 24.6 and 28.9 % in the EMP/VBL and EMP arms , respectively . There was no correlation between PSA response and survival . While the PSA response in the patients tested was less than half that recorded in the North American studies , the toxicity of EMP monotherapy or in combination with VBL was much higher than expected . Further research on more effective and less toxic treatment strategies for hormone refractory prostate cancer is mandatory .
15759
Intervention_Pharmacological
estramustine and vinblastine combination chemotherapy
15760
Intervention_Pharmacological
estramustine alone
15761
Intervention_Pharmacological
chemotherapy with estramustine phosphate ( EMP ) and vinblastine ( VBL )
15762
Intervention_Pharmacological
oral EMP ( 10 mg kg day continuously ) or oral EMP in combination with intravenous VBL
15763
Intervention_Pharmacological
EMP/VBL
15764
Intervention_Pharmacological
EMP
15765
Intervention_Pharmacological
EMP
15766
Intervention_Pharmacological
VBL
15767
Outcome_Adverse-effects
toxicity
15768
Outcome_Physical
PSA response
15769
Outcome_Physical
time to progression
15770
Outcome_Mortality
survival
15771
Outcome_Adverse-effects
Toxicity
15772
Outcome_Other
mean treatment duration
15773
Outcome_Physical
median time to PSA progression
15774
Outcome_Mortality
median survival time
15775
Outcome_Physical
PSA response rate
15776
Outcome_Physical
PSA response
15777
Outcome_Mortality
survival
15778
Outcome_Physical
PSA response
15779
Outcome_Adverse-effects
toxicity of EMP monotherapy
15780
Outcome_Other
effective
15781
Outcome_Adverse-effects
toxic
15782
Participant_Condition
progressive hormone-escaped metastatic prostate cancer
15783
Participant_Sample-size
92