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 Journal Article
| Authors: | Philips, G. K.; Halabi, S.; Sanford, B. L.; Bajorin, D.; Small, E. J. |
| Article Title: | 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 |
| Abstract: | 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/m2 on day 1, gemcitabine 1000 mg/m2 on day 1 and 8, administered at a fixed dose rate of 10 mg/m2/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. © 2007 The Authors. |
| Keywords: | adult; cancer survival; clinical article; controlled study; treatment outcome; aged; middle aged; clinical trial; fatigue; neutropenia; cisplatin; cancer combination chemotherapy; diarrhea; dose response; drug efficacy; drug withdrawal; side effect; treatment duration; gemcitabine; chemotherapy; controlled clinical trial; multiple cycle treatment; phase 2 clinical trial; anemia; nausea; thrombocytopenia; antineoplastic combined chemotherapy protocols; dehydration; maintenance therapy; deep vein thrombosis; kidney failure; urogenital tract cancer; dyspnea; febrile neutropenia; hyperuricemia; rash; lung embolism; chemotherapy induced emesis; hyponatremia; hypotension; survival time; urologic neoplasms; urothelium; multicenter study; urinary tract infection; gefitinib; carcinoma; egfr; carcinoma, transitional cell; deoxycytidine; quinazolines; brain ischemia; infection complication; creatinine clearance; brain infarction; urothelial; ureter obstruction; carotid artery thrombosis; urothelial tract carcinoma |
| Journal Title: | BJU International |
| Volume: | 101 |
| Issue: | 1 |
| ISSN: | 1464-4096 |
| Publisher: | Wiley Blackwell |
| Date Published: | 2008-01-01 |
| Start Page: | 20 |
| End Page: | 25 |
| Language: | English |
| DOI: | 10.1111/j.1464-410X.2007.07226.x |
| PUBMED: | 17922873 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 17" - "Export Date: 17 November 2011" - "CODEN: BJINF" - "Source: Scopus" |
