TY - JOUR
T1 - Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium
T2 - A trial of the Eastern Cooperative Oncology Group
AU - Dreicer, Robert
AU - Manola, Judith
AU - Schneider, Daniel J.
AU - Schwerkoske, John F.
AU - George, Christopher S.
AU - Roth, Bruce J.
AU - Wilding, George
PY - 2003/6/1
Y1 - 2003/6/1
N2 - BACKGROUND. Gemcitabine and docetaxel are active agents in advanced urothelial carcinoma. A Phase II trial of this combination was performed to determine the activity and toxicity of these agents in a multiinstitutional setting in patients previously treated with one prior chemotherapy regimen. METHODS. Twenty-nine eligible patients with advanced urothelial carcinoma were treated with docetaxel at a dose of 40 mg/m2 over 1 hour followed by gemcitabine, 800 mg/m2, over 30 minutes, both intravenously (i.v.) on Days 1 and 8. Cycles were repeated every 21 days until disease progression or a maximum of 6 cycles. RESULTS. Five patients obtained an objective response for an overall response rate of 17% (90% confidence interval, 7-33%). One patient achieved a complete clinical response. The median overall survival of the group was 7.7 months. Toxicity was moderate with granulocytopenia, anorexia, and fatigue being the most commonly noted side effects. CONCLUSIONS. Gemcitabine and docetaxel is an active second-line combination in patients with advanced urothelial carcinoma. Responses in visceral, lymph node, and soft tissues sites were observed. Granulocytopenia without fever, fatigue, and anorexia was common. Thromboembolic symptoms were reported and are of concern. The combination of gemcitabine and docetaxel has the potential to palliate a subset of previously treated patients with an adequate performance status.
AB - BACKGROUND. Gemcitabine and docetaxel are active agents in advanced urothelial carcinoma. A Phase II trial of this combination was performed to determine the activity and toxicity of these agents in a multiinstitutional setting in patients previously treated with one prior chemotherapy regimen. METHODS. Twenty-nine eligible patients with advanced urothelial carcinoma were treated with docetaxel at a dose of 40 mg/m2 over 1 hour followed by gemcitabine, 800 mg/m2, over 30 minutes, both intravenously (i.v.) on Days 1 and 8. Cycles were repeated every 21 days until disease progression or a maximum of 6 cycles. RESULTS. Five patients obtained an objective response for an overall response rate of 17% (90% confidence interval, 7-33%). One patient achieved a complete clinical response. The median overall survival of the group was 7.7 months. Toxicity was moderate with granulocytopenia, anorexia, and fatigue being the most commonly noted side effects. CONCLUSIONS. Gemcitabine and docetaxel is an active second-line combination in patients with advanced urothelial carcinoma. Responses in visceral, lymph node, and soft tissues sites were observed. Granulocytopenia without fever, fatigue, and anorexia was common. Thromboembolic symptoms were reported and are of concern. The combination of gemcitabine and docetaxel has the potential to palliate a subset of previously treated patients with an adequate performance status.
KW - Docetaxel
KW - Gemcitabine
KW - Phase II trial
KW - Urothelial carcinoma
UR - http://www.scopus.com/inward/record.url?scp=0038182762&partnerID=8YFLogxK
U2 - 10.1002/cncr.11413
DO - 10.1002/cncr.11413
M3 - Article
C2 - 12767086
AN - SCOPUS:0038182762
SN - 0008-543X
VL - 97
SP - 2743
EP - 2747
JO - Cancer
JF - Cancer
IS - 11
ER -