A phase I dose finding study of cisplatin, gemcitabine, and weekly docetaxel for patients with advanced transitional cell cancer.
OBJECTIVE
Efficacious regimens are needed for the treatment of metastatic bladder cancer. The aim of this study was to determine the toxicity and phase II dose of a triplet regimen of cisplatin, gemcitabine, and weekly docetaxel for patients with advanced transitional cell carcinoma.


METHODS
Thirteen patients were enrolled to the study: 3 to dose level 1 (cisplatin 70 mg/m2 on day 1; gemcitabine 1000 mg/m2, day 1 and 8; and docetaxel 30 mg/m2, day 1 and 8, every 21 days), and 10 to dose level -1 (cisplatin 70 mg/m2 on day 1; gemcitabine 800 mg/m2, day 1 and 8; and docetaxel 30 mg/m2, day 1 and 8, every 21 days).


RESULTS
Grade 3-4 hematologic toxicities included neutropenia (40%) and thrombocytopenia (20%). Grade 3 nonhematologic toxicity was restricted to diarrhea. There were 2 early deaths: 1 from a suspected pulmonary embolism and another from sepsis. In 11 patients who received > or =2 cycles the response rate was 73%.


CONCLUSIONS
The recommended phase II dose of this triplet regimen in advanced transitional cell carcinoma is cisplatin 70 mg/m2 on day 1; gemcitabine 800 mg/m2 day 1 and 8; and docetaxel 30 mg/m2 day 1 and 8, repeated every 21 days. The preliminary objective response rate was high in this cohort of patients.
Tinker
Anna
A
BC Cancer Agency, Vancouver, BC, Canada.
Winquist
Eric
E
Canil
Christina
C
Moore
Malcolm
M
Murray
R Nevin
RN
Chi
Kim N
KN
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D002945:Cisplatin; D000093542:Gemcitabine