A phase I/II study of gemcitabine and fractionated cisplatin in an outpatient setting using a 21-day schedule in patients with advanced and metastatic bladder cancer
Autor: | Daniel H. Palmer, D. R. Peake, Nicholas D. James, J I Geh, David Spooner, Syed A. Hussain, Deborah D. Stocken, P. Riley |
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Jazyk: | angličtina |
Rok vydání: | 2004 |
Předmět: |
Adult
Male Cancer Research Vincristine medicine.medical_specialty Maximum Tolerated Dose medicine.drug_class medicine.medical_treatment Renal function Antineoplastic Agents chemotherapy Kidney Kidney Function Tests Antimetabolite Gastroenterology Deoxycytidine chemistry.chemical_compound Clinical Internal medicine Antineoplastic Combined Chemotherapy Protocols Outpatients medicine Humans Aged fractionated cisplatin Chemotherapy Carcinoma Transitional Cell business.industry gemcitabine Middle Aged Gemcitabine Surgery Viscera Treatment Outcome Oncology chemistry Urinary Bladder Neoplasms Lymphatic Metastasis Toxicity outpatient bladder cancer Methotrexate Female Cisplatin business medicine.drug |
Zdroj: | British Journal of Cancer |
ISSN: | 1532-1827 0007-0920 |
Popis: | A randomised phase III trial of MVAC (methotrexate, vincristine, doxorubicin, cisplatin) vs gemcitabine and cisplatin (GC) (G 1000 mg m(-2) days 1, 8, and 15 plus C 70 mg m(-2) day 2, q 4 wks) indicated GC had similar efficacy and lower toxicity (JCO 2000). Significant haematologic toxicities in the GC arm occurred on day 15, necessitating dose adjustments in 37% of cycles. We conducted a phase I/II dose escalation trial using GC on a 21-day cycle, with G and C split between days 1 and 8. The objective of the study to define maximum-tolerated dose and dose-limiting toxicity (DLT), objective response rate, and overall survival. In all, 32 patients with locally advanced, relapsed, or metastatic disease received: dose level 1, G/C 1000/35; level 2, 1100/35; level 3, 1200/35; level 4, 1200/45 mg m(-2) (G and C given on days 1 and 8 every 3 wks). A total of 19 patients had glomerular filtration rate |
Databáze: | OpenAIRE |
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