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

Donald S. Kaufman; Michael A. Carducci; Tim M. Kuzel; Mary B. Todd; William K. Oh; Matthew R. Smith; Zhishen Ye; Steven J. Nicol; Walter M. Stadler

doi:10.1016/j.urolonc.2004.01.002

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

Donald S. Kaufman, Michael A. Carducci, Tim M. Kuzel, Mary B. Todd, William K. Oh, Matthew R. Smith, Zhishen Ye, Steven J. Nicol, Walter M. Stadler^*

^*Corresponding author for this work

Dermatology

Research output: Contribution to journal › Article › peer-review

57 Scopus citations

Abstract

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/m² and 150 mg/m², 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.

Original language	English (US)
Pages (from-to)	393-397
Number of pages	5
Journal	Urologic Oncology: Seminars and Original Investigations
Volume	22
Issue number	5
DOIs	https://doi.org/10.1016/j.urolonc.2004.01.002
State	Published - 2004

Funding

This research was supported by Eli Lilly & Co.

Keywords

Bladder cancer
Clinical trial
Gemcitabine
Paclitaxel
Urothelial cancer

ASJC Scopus subject areas

Urology
Oncology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.urolonc.2004.01.002

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Kaufman, D. S., Carducci, M. A., Kuzel, T. M., Todd, M. B., Oh, W. K., Smith, M. R., Ye, Z., Nicol, S. J., & Stadler, W. M. (2004). A multi-institutional phase II trial of gemcitabine plus paclitaxel in patients with locally advanced or metastatic urothelial cancer. Urologic Oncology: Seminars and Original Investigations, 22(5), 393-397. https://doi.org/10.1016/j.urolonc.2004.01.002

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abstract = "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/m2 and 150 mg/m2, 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.",

keywords = "Bladder cancer, Clinical trial, Gemcitabine, Paclitaxel, Urothelial cancer",

author = "Kaufman, {Donald S.} and Carducci, {Michael A.} and Kuzel, {Tim M.} and Todd, {Mary B.} and Oh, {William K.} and Smith, {Matthew R.} and Zhishen Ye and Nicol, {Steven J.} and Stadler, {Walter M.}",

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doi = "10.1016/j.urolonc.2004.01.002",

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Kaufman, DS, Carducci, MA, Kuzel, TM, Todd, MB, Oh, WK, Smith, MR, Ye, Z, Nicol, SJ & Stadler, WM 2004, 'A multi-institutional phase II trial of gemcitabine plus paclitaxel in patients with locally advanced or metastatic urothelial cancer', Urologic Oncology: Seminars and Original Investigations, vol. 22, no. 5, pp. 393-397. https://doi.org/10.1016/j.urolonc.2004.01.002

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T1 - A multi-institutional phase II trial of gemcitabine plus paclitaxel in patients with locally advanced or metastatic urothelial cancer

AU - Kaufman, Donald S.

AU - Carducci, Michael A.

AU - Kuzel, Tim M.

AU - Todd, Mary B.

AU - Oh, William K.

AU - Smith, Matthew R.

AU - Ye, Zhishen

AU - Nicol, Steven J.

AU - Stadler, Walter M.

N1 - Funding Information: This research was supported by Eli Lilly & Co.

PY - 2004

Y1 - 2004

N2 - 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/m2 and 150 mg/m2, 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.

AB - 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/m2 and 150 mg/m2, 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.

KW - Bladder cancer

KW - Clinical trial

KW - Gemcitabine

KW - Paclitaxel

KW - Urothelial cancer

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

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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