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A phase II trial of cisplatin, fixed dose-rate gemcitabine and gefitinib for advanced urothelial tract carcinoma: results of the Cancer and Leukaemia Group B 90102.

Publication ,  Journal Article
Philips, GK; Halabi, S; Sanford, BL; Bajorin, D; Small, EJ; Cancer and Leukaemia Group B
Published in: BJU Int
January 2008

OBJECTIVE: To conduct a phase II trial to determine the efficacy of cisplatin, a fixed dose-rate infusion of gemcitabine and gefitinib (an orally active epidermal growth factor receptor tyrosine kinase inhibitor) in patients with advanced urothelial carcinoma. PATIENTS AND METHODS: Eligible patients had previously untreated measurable disease, an Eastern Cooperative Oncology Group performance status of 0-2 and creatinine clearance of >50 mL/min. The treatment regimen consisted of cisplatin 70 mg/m(2) on day 1, gemcitabine 1000 mg/m(2) on day 1 and 8, administered at a fixed dose rate of 10 mg/m(2)/min, given every 3 weeks concurrent with gefitinib 500 mg/day orally for a maximum of six cycles. Maintenance gefitinib 500 mg/day was continued for responding or stable disease. RESULTS: In all, 27 patients were accrued before the study was halted because the dose-limiting toxicity (DLT) exceeded pre-established stopping rules. The DLT events were two grade 5 (one infection, one cardiovascular accident) and three with grade 4 non-haematological toxicity. In 25 evaluable patients there were nine objective responses, for an overall response rate of 36% (95% confidence interval, CI, 18-57%). The median (95% CI) survival time was 11.1 (5.2-35.3) months. CONCLUSION: The combination of cisplatin, fixed dose-rate gemcitabine and gefitinib is active in advanced TCC, although the relative contribution of gefitinib cannot be determined. However, this regimen was associated with excessive toxicity.

Duke Scholars

Published In

BJU Int

DOI

EISSN

1464-410X

Publication Date

January 2008

Volume

101

Issue

1

Start / End Page

20 / 25

Location

England

Related Subject Headings

  • Urothelium
  • Urology & Nephrology
  • Urologic Neoplasms
  • Treatment Outcome
  • Quinazolines
  • Middle Aged
  • Male
  • Humans
  • Gemcitabine
  • Gefitinib
 

Citation

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Philips, G. K., Halabi, S., Sanford, B. L., Bajorin, D., Small, E. J., & Cancer and Leukaemia Group B. (2008). A phase II trial of cisplatin, fixed dose-rate gemcitabine and gefitinib for advanced urothelial tract carcinoma: results of the Cancer and Leukaemia Group B 90102. BJU Int, 101(1), 20–25. https://doi.org/10.1111/j.1464-410X.2007.07226.x
Philips, George K., Susan Halabi, Ben L. Sanford, Dean Bajorin, Eric J. Small, and Cancer and Leukaemia Group B. “A phase II trial of cisplatin, fixed dose-rate gemcitabine and gefitinib for advanced urothelial tract carcinoma: results of the Cancer and Leukaemia Group B 90102.BJU Int 101, no. 1 (January 2008): 20–25. https://doi.org/10.1111/j.1464-410X.2007.07226.x.
Philips GK, Halabi S, Sanford BL, Bajorin D, Small EJ, Cancer and Leukaemia Group B. A phase II trial of cisplatin, fixed dose-rate gemcitabine and gefitinib for advanced urothelial tract carcinoma: results of the Cancer and Leukaemia Group B 90102. BJU Int. 2008 Jan;101(1):20–5.
Philips, George K., et al. “A phase II trial of cisplatin, fixed dose-rate gemcitabine and gefitinib for advanced urothelial tract carcinoma: results of the Cancer and Leukaemia Group B 90102.BJU Int, vol. 101, no. 1, Jan. 2008, pp. 20–25. Pubmed, doi:10.1111/j.1464-410X.2007.07226.x.
Philips GK, Halabi S, Sanford BL, Bajorin D, Small EJ, Cancer and Leukaemia Group B. A phase II trial of cisplatin, fixed dose-rate gemcitabine and gefitinib for advanced urothelial tract carcinoma: results of the Cancer and Leukaemia Group B 90102. BJU Int. 2008 Jan;101(1):20–25.
Journal cover image

Published In

BJU Int

DOI

EISSN

1464-410X

Publication Date

January 2008

Volume

101

Issue

1

Start / End Page

20 / 25

Location

England

Related Subject Headings

  • Urothelium
  • Urology & Nephrology
  • Urologic Neoplasms
  • Treatment Outcome
  • Quinazolines
  • Middle Aged
  • Male
  • Humans
  • Gemcitabine
  • Gefitinib