TY - JOUR
T1 - Paclitaxel, estramustine phosphate, and carboplatin in patients with advanced prostate cancer
AU - Kelly, W. K.
AU - Curley, T.
AU - Slovin, S.
AU - Heller, G.
AU - McCaffrey, J.
AU - Bajorin, D.
AU - Ciolino, A.
AU - Regan, K.
AU - Schwartz, M.
AU - Kantoff, P.
AU - George, D.
AU - Oh, W.
AU - Smith, M.
AU - Kaufman, D.
AU - Small, E. J.
AU - Schwartz, L.
AU - Larson, S.
AU - Tong, W.
AU - Scher, H.
N1 - Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2001/1/1
Y1 - 2001/1/1
N2 - Purpose: To determine the safety and activity of weekly paclitaxel in combination with estramustine and carboplatin (TEC) in patients with advanced prostate cancer. Patients and Methods: In a dose-escalation study, patients with advanced prostate cancer were administered paclitaxel (weekly 1-hour infusions of 60 to 100 mg/m2), oral estramustine (10 mg/kg), and carboplatin (area under the curve, 6 mg/mL-min every 4 weeks). Paclitaxel levels were determined 0, 30, 60, 90, and 120 minutes and 18 hours after infusion, and a concentration-time curve was estimated. Once a safe dose was established, a multi-institutional phase II trial was conducted in patients with progressive androgen-independent disease. Results: Fifty-six patients with progressive androgen-independent disease were treated for a median of four cycles. The dose of paclitaxel was escalated from 60 to 100 mg/m2 without the occurrence of DLT. Posttherapy decreases in serum prostate-specific antigen levels of 50%, 80%, and 90% were seen in 67%, 48%, and 39% (95% confidence interval, 55% to 79%, 35% to 61%, 26% to 52%) of the patients, respectively. Of the 33 patients with measurable disease, two (6%) had a complete response and 13 (39%) had a partial response. The overall median time to progression was 21 weeks, and the median survival time for all patients was 19.9 months. Major grade 3 or 4 adverse effects were thromboembolic disease (in 25% of patients), hyperglycemia (in 38%), and hypophosphatemia (in 42%). Significant leukopenia, thrombocytopenia, and peripheral neuropathy were not observed. Conclusion: TEC has significant antitumor activity and is well tolerated in patients with progressive androgen-independent prostate cancer.
AB - Purpose: To determine the safety and activity of weekly paclitaxel in combination with estramustine and carboplatin (TEC) in patients with advanced prostate cancer. Patients and Methods: In a dose-escalation study, patients with advanced prostate cancer were administered paclitaxel (weekly 1-hour infusions of 60 to 100 mg/m2), oral estramustine (10 mg/kg), and carboplatin (area under the curve, 6 mg/mL-min every 4 weeks). Paclitaxel levels were determined 0, 30, 60, 90, and 120 minutes and 18 hours after infusion, and a concentration-time curve was estimated. Once a safe dose was established, a multi-institutional phase II trial was conducted in patients with progressive androgen-independent disease. Results: Fifty-six patients with progressive androgen-independent disease were treated for a median of four cycles. The dose of paclitaxel was escalated from 60 to 100 mg/m2 without the occurrence of DLT. Posttherapy decreases in serum prostate-specific antigen levels of 50%, 80%, and 90% were seen in 67%, 48%, and 39% (95% confidence interval, 55% to 79%, 35% to 61%, 26% to 52%) of the patients, respectively. Of the 33 patients with measurable disease, two (6%) had a complete response and 13 (39%) had a partial response. The overall median time to progression was 21 weeks, and the median survival time for all patients was 19.9 months. Major grade 3 or 4 adverse effects were thromboembolic disease (in 25% of patients), hyperglycemia (in 38%), and hypophosphatemia (in 42%). Significant leukopenia, thrombocytopenia, and peripheral neuropathy were not observed. Conclusion: TEC has significant antitumor activity and is well tolerated in patients with progressive androgen-independent prostate cancer.
UR - http://www.scopus.com/inward/record.url?scp=0035151545&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0035151545&partnerID=8YFLogxK
U2 - 10.1200/JCO.2001.19.1.44
DO - 10.1200/JCO.2001.19.1.44
M3 - Article
C2 - 11134194
AN - SCOPUS:0035151545
SN - 0732-183X
VL - 19
SP - 44
EP - 53
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 1
ER -