A multi-institutional phase II trial of gemcitabine plus paclitaxel in patients with locally advanced or metastatic urothelial cancer

• Published in: Urologic oncology Vol. 22; no. 5; pp. 393 - 397
• Main Authors: Kaufman, Donald S., Carducci, Michael A., Kuzel, Tim M., Todd, Mary B., Oh, William K., Smith, Matthew R., Ye, Zhishen, Nicol, Steven J., Stadler, Walter M.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01-09-2004; Elsevier Science
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Bladder cancer; Clinical trial; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Female; Gemcitabine; Humans; Infusions, Intravenous; Kidney - physiology; Male; Medical sciences; Middle Aged; Neoplasm Metastasis; Nephrology. Urinary tract diseases; Paclitaxel; Paclitaxel - administration & dosage; Survival Analysis; Treatment Outcome; Tumors; Tumors of the urinary system; Ureteral Neoplasms - drug therapy; Ureteral Neoplasms - pathology; Urinary Bladder Neoplasms - drug therapy; Urinary Bladder Neoplasms - pathology; Urinary tract. Prostate gland; Urothelial cancer; Urothelial cancer; Clinical trial; Gemcitabine; Bladder cancer; Paclitaxel; Antineoplastic agent; Nephrology; Metastasis; Urinary tract; Urology; Cancerology; Taxane derivatives; Phase II trial; Advanced stage; Antimitotic; Pyrimidine nucleoside; Human; Drug combination; Urinary system disease; Urinary tract disease; Malignant tumor; Bladder cancer: Clinical trial; Antimetabolic; Urinary system; Bladder disease; Metastatic; Fluorine Organic compounds
• ISSN: 1078-1439; 1873-2496
• DOI: 10.1016/j.urolonc.2004.01.002

The purpose of the study was to evaluate response and survival in patients with metastatic urothelial cancer treated with combination gemcitabine and paclitaxel administered on a biweekly schedule at doses of 3000 mg/m
2 and 150 mg/m
2, respectively. Patients with adequate organ function and performance status were accrued through 7 institutions, stratified by prior therapy status, and treated as noted. Response was evaluated by 1979 bi-dimensional World Health Organization (WHO) criteria. Of 55 eligible patients, 17 had a partial and 5 had a complete response rate for an overall response rate of 40% (27–54%). One complete response and one partial response were observed in the 6 previously treated patients. Overall median survival was 11.8 months (11.9 months in the chemonaive cohort). Grade 3 or 4 myelosuppression occurred in 56%, but only 4 serious infections were observed. We conclude that because of a lower than expected complete response rate, even when corrected for prognostic groupings, this regimen is not recommended for routine use in patients with metastatic urothelial cancer. Insufficient patients with poor renal function or prior therapy were accrued to reach conclusions regarding its utility in these subgroups.