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Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896)

A trial of the Eastern Cooperative Oncology Group

  1. David J. Vaughn M.D.1,†,*,
  2. Judith Manola M.S.2,
  3. Robert Dreicer M.D.3,
  4. William See M.D.4,
  5. Ralph Levitt M.D.5,
  6. George Wilding M.D.6

Article first published online: 19 AUG 2002

DOI: 10.1002/cncr.10782

Issue

Cancer

Cancer

Volume 95, Issue 5, pages 1022–1027, 1 September 2002

Additional Information

How to Cite

Vaughn, D. J., Manola, J., Dreicer, R., See, W., Levitt, R. and Wilding, G. (2002), Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896). Cancer, 95: 1022–1027. doi: 10.1002/cncr.10782

Author Information

  1. 1

    Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania

  2. 2

    Dana–Farber Cancer Institute, Boston, Massachusetts

  3. 3

    Cleveland Clinic Foundation, Cleveland, Ohio

  4. 4

    Medical College of Wisconsin, Milwaukee, Wisconsin

  5. 5

    Roger Marris Cancer Center, Fargo, North Dakota

  6. 6

    University of Wisconsin, Madison, Wisconsin

  1. †

    Fax: (215) 662–7804

*Abramson Cancer Center, University of Pennsylvania, 16 Penn Tower, 3400 Spruce Street, Philadelphia, PA 19104

Publication History

  1. Issue published online: 19 AUG 2002
  2. Article first published online: 19 AUG 2002
  3. Manuscript Accepted: 3 APR 2002
  4. Manuscript Revised: 13 MAR 2002
  5. Manuscript Received: 10 JAN 2002

Funded by

  • Public Health Service. Grant Numbers: CA23318, CA66636, CA21115, CA15488, CA21076, CA13650
  • National Institutes of Health
  • Department of Health and Human Services

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Keywords:

  • bladder carcinoma;
  • renal dysfunction;
  • chemotherapy;
  • paclitaxel;
  • carboplatin

Chemotherapy options for patients with advanced urothelial carcinoma and renal dysfunction are limited. E2896, a Phase II trial of paclitaxel and carboplatin in these patients, is the first cooperative group study for this patient population and will serve as a reference for future trials.

Abstract

BACKGROUND

Chemotherapy options for the patients with advanced urothelial carcinoma and renal dysfunction are limited. The authors performed a Phase II trial of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction.

METHODS

Forty-two patients were accrued; 37 eligible patients were treated. Patients received paclitaxel 225 mg/m2 over three hours followed by carboplatin targeted area under the concentration-time curve = 6 mg/mL · minute every three weeks for up to six cycles.

RESULTS

The median number of cycles received was four (range, one to six). The objective response rate was 24.3% (95% confidence interval, 11.9–41.7%). The median progression free survival was 3 months and the median overall survival was 7.1 months. The number of poor prognostic risk factors (Eastern Cooperative Oncology Group performance status > 1 or lung, liver, or bone metastases) significantly predicted for survival. The most common ≥ 1 Grade 3 toxicities included granulocytopenia (60%) and neurotoxicity (35%).

CONCLUSIONS

Paclitaxel/carboplatin is a chemotherapy option for patients with advanced urothelial carcinoma and renal dysfunction. Future trials in chemotherapy development for this patient population are warranted. Cancer 2002;95:1022–7. © 2002 American Cancer Society.

DOI 10.1002/cncr.10782

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