Phase I/II study of a combined gemcitabine, etoposide, and cisplatin chemotherapy regimen for metastatic urothelial carcinoma

Cancer
Tetsuro TsukamotoIwao Fukui

Abstract

The authors attempted to determine the maximum tolerated dose (MTD) of gemcitabine in combination with etoposide and cisplatin as a chemotherapy regimen and investigated the safety and antitumor activity with the recommended doses of gemcitabine with etoposide and cisplatin for patients with metastatic urothelial carcinoma. Patients age 75 years or younger with measurable lesions, creatinine clearance>or=50 mL per minute, and adequate bone marrow and hepatic function were studied. Etoposide and cisplatin were given on Days 1 through 3 at fixed doses of 75 mg/m2 and 25 mg/m2, respectively, and gemcitabine was given on Days 1, 8, and 15. In the Phase I component, gemcitabine was administered at increasing doses from 600 mg/m2. Cycles were repeated every 28 days unless progressive disease was encountered. In Phase I, with the initially fixed doses of etoposide and cisplatin, the MTD of gemcitabine could not be determined because of the occurrence of dose-limiting toxicity at Level 1 in all 3 patients. When the doses of etoposide and cisplatin were modified to 60 mg/m2 and 20 mg/m2, respectively, the MTD of gemcitabine was 1000 mg/m2. Next, 19 additional patients were entered into Phase II with the recommended gemcitabine dose of 8...Continue Reading

References

Jun 1, 1990·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·C J LogothetisR G Kilbourn
Feb 1, 1994·Annals of Oncology : Official Journal of the European Society for Medical Oncology·C F PolleraF Calabresi
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Dec 11, 2003·The Journal of Urology·Arlene O Siefker-RadtkeRandall E Millikan
Mar 1, 2005·International Journal of Urology : Official Journal of the Japanese Urological Association·Manabu TadokoroIwao Fukui

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