A phase II study of paclitaxel and ifosfamide for patients with advanced refractory carcinoma of the urothelium

Christopher J. Sweeney, Stephen D. Williams, David E. Finch, Richard Bihrle, Richard Foster, Mary Collins, Susan Fox, Bruce J. Roth

Research output: Contribution to journalArticle

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Abstract

BACKGROUND. Cisplatin-based combination chemotherapy for patients with advanced transitional cell carcinoma (TCC) of the urothelium has limitations, and new therapies need to be evaluated. METHODS. Ifosfamide 1.0 gm/m2 on Days 1-4 and paclitaxel 135 mg/m2 by 24-hour infusion on Day 4 were administered to 26 patients with locally unresectable or metastatic TCC. Cycles were repeated every 21 days for a maximum of 6 cycles; dose escalation was dependent on whether Grade 3 or 4 toxicities occurred. RESULTS. There were 24 males and 2 females, with a median age of 66 years and a median Eastern Cooperative Oncology Group performance status of 0. The median number of cycles administered was 3. Twelve patients had Grade 3 or 4 hematologic toxicities, including 1 patient who died of a gastrointestinal hemorrhage while pancytopenic. There were no episodes of neutropenic fever. Two patients each had a complete response (CR) that lasted 5 and 28 months, respectively (response rate: 15%; 95% CI: 2-45%), among the 13 patients who had received prior chemotherapy. Of the 13 patients without prior chemotherapy, there were 3 with complete responses and 1 with a partial response ranging from 8 to 25+ months (RR: 30.7%; 95% CI: 9-61%). CONCLUSIONS. The combination of ifosfamide and paclitaxel is well tolerated and can produce objective responses in patients who are chemonaive or have had prior therapy. For previously untreated patients, the addition of ifosfamide does not appear to result in a better response rate than single agent paclitaxel; and for previously treated patients, the addition of paclitaxel does not appear to result in a better response rate than single agent ifosfamide.

Original languageEnglish
Pages (from-to)514-518
Number of pages5
JournalCancer
Volume86
Issue number3
DOIs
StatePublished - Aug 1 1999

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Urothelium
Ifosfamide
Paclitaxel
Carcinoma
Transitional Cell Carcinoma
Drug Therapy
Gastrointestinal Hemorrhage
Combination Drug Therapy
Cisplatin
Fever

Keywords

  • Ifosfamide
  • Paclitaxel
  • Phase II study
  • Urothelial carcinoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A phase II study of paclitaxel and ifosfamide for patients with advanced refractory carcinoma of the urothelium. / Sweeney, Christopher J.; Williams, Stephen D.; Finch, David E.; Bihrle, Richard; Foster, Richard; Collins, Mary; Fox, Susan; Roth, Bruce J.

In: Cancer, Vol. 86, No. 3, 01.08.1999, p. 514-518.

Research output: Contribution to journalArticle

Sweeney, Christopher J. ; Williams, Stephen D. ; Finch, David E. ; Bihrle, Richard ; Foster, Richard ; Collins, Mary ; Fox, Susan ; Roth, Bruce J. / A phase II study of paclitaxel and ifosfamide for patients with advanced refractory carcinoma of the urothelium. In: Cancer. 1999 ; Vol. 86, No. 3. pp. 514-518.
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abstract = "BACKGROUND. Cisplatin-based combination chemotherapy for patients with advanced transitional cell carcinoma (TCC) of the urothelium has limitations, and new therapies need to be evaluated. METHODS. Ifosfamide 1.0 gm/m2 on Days 1-4 and paclitaxel 135 mg/m2 by 24-hour infusion on Day 4 were administered to 26 patients with locally unresectable or metastatic TCC. Cycles were repeated every 21 days for a maximum of 6 cycles; dose escalation was dependent on whether Grade 3 or 4 toxicities occurred. RESULTS. There were 24 males and 2 females, with a median age of 66 years and a median Eastern Cooperative Oncology Group performance status of 0. The median number of cycles administered was 3. Twelve patients had Grade 3 or 4 hematologic toxicities, including 1 patient who died of a gastrointestinal hemorrhage while pancytopenic. There were no episodes of neutropenic fever. Two patients each had a complete response (CR) that lasted 5 and 28 months, respectively (response rate: 15{\%}; 95{\%} CI: 2-45{\%}), among the 13 patients who had received prior chemotherapy. Of the 13 patients without prior chemotherapy, there were 3 with complete responses and 1 with a partial response ranging from 8 to 25+ months (RR: 30.7{\%}; 95{\%} CI: 9-61{\%}). CONCLUSIONS. The combination of ifosfamide and paclitaxel is well tolerated and can produce objective responses in patients who are chemonaive or have had prior therapy. For previously untreated patients, the addition of ifosfamide does not appear to result in a better response rate than single agent paclitaxel; and for previously treated patients, the addition of paclitaxel does not appear to result in a better response rate than single agent ifosfamide.",
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AU - Sweeney, Christopher J.

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AU - Foster, Richard

AU - Collins, Mary

AU - Fox, Susan

AU - Roth, Bruce J.

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N2 - BACKGROUND. Cisplatin-based combination chemotherapy for patients with advanced transitional cell carcinoma (TCC) of the urothelium has limitations, and new therapies need to be evaluated. METHODS. Ifosfamide 1.0 gm/m2 on Days 1-4 and paclitaxel 135 mg/m2 by 24-hour infusion on Day 4 were administered to 26 patients with locally unresectable or metastatic TCC. Cycles were repeated every 21 days for a maximum of 6 cycles; dose escalation was dependent on whether Grade 3 or 4 toxicities occurred. RESULTS. There were 24 males and 2 females, with a median age of 66 years and a median Eastern Cooperative Oncology Group performance status of 0. The median number of cycles administered was 3. Twelve patients had Grade 3 or 4 hematologic toxicities, including 1 patient who died of a gastrointestinal hemorrhage while pancytopenic. There were no episodes of neutropenic fever. Two patients each had a complete response (CR) that lasted 5 and 28 months, respectively (response rate: 15%; 95% CI: 2-45%), among the 13 patients who had received prior chemotherapy. Of the 13 patients without prior chemotherapy, there were 3 with complete responses and 1 with a partial response ranging from 8 to 25+ months (RR: 30.7%; 95% CI: 9-61%). CONCLUSIONS. The combination of ifosfamide and paclitaxel is well tolerated and can produce objective responses in patients who are chemonaive or have had prior therapy. For previously untreated patients, the addition of ifosfamide does not appear to result in a better response rate than single agent paclitaxel; and for previously treated patients, the addition of paclitaxel does not appear to result in a better response rate than single agent ifosfamide.

AB - BACKGROUND. Cisplatin-based combination chemotherapy for patients with advanced transitional cell carcinoma (TCC) of the urothelium has limitations, and new therapies need to be evaluated. METHODS. Ifosfamide 1.0 gm/m2 on Days 1-4 and paclitaxel 135 mg/m2 by 24-hour infusion on Day 4 were administered to 26 patients with locally unresectable or metastatic TCC. Cycles were repeated every 21 days for a maximum of 6 cycles; dose escalation was dependent on whether Grade 3 or 4 toxicities occurred. RESULTS. There were 24 males and 2 females, with a median age of 66 years and a median Eastern Cooperative Oncology Group performance status of 0. The median number of cycles administered was 3. Twelve patients had Grade 3 or 4 hematologic toxicities, including 1 patient who died of a gastrointestinal hemorrhage while pancytopenic. There were no episodes of neutropenic fever. Two patients each had a complete response (CR) that lasted 5 and 28 months, respectively (response rate: 15%; 95% CI: 2-45%), among the 13 patients who had received prior chemotherapy. Of the 13 patients without prior chemotherapy, there were 3 with complete responses and 1 with a partial response ranging from 8 to 25+ months (RR: 30.7%; 95% CI: 9-61%). CONCLUSIONS. The combination of ifosfamide and paclitaxel is well tolerated and can produce objective responses in patients who are chemonaive or have had prior therapy. For previously untreated patients, the addition of ifosfamide does not appear to result in a better response rate than single agent paclitaxel; and for previously treated patients, the addition of paclitaxel does not appear to result in a better response rate than single agent ifosfamide.

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