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Cancer Chemother Pharmacol. 2009 Jun;64(1):45-51. doi: 10.1007/s00280-008-0844-1. Epub 2008 Oct 8.

Dose-escalation study of fixed-dose rate gemcitabine combined with capecitabine in advanced solid malignancies.

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  • 1University of Wisconsin Paul P Carbone Comprehensive Cancer Center Madison, Madison, WI 53792, USA.



To define dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of capecitabine with fixed-dose rate (FDR) gemcitabine.


Eligible adults (advanced solid tumor; performance status <or=2) received capecitabine 500 mg/m(2) PO BID days 1-14 and FDR gemcitabine (400-1,000 mg/m(2) escalated by 200 mg/m(2) increments) at 10 mg/m(2)/min days 1 and 8 on a 21-day cycle. A traditional 3 + 3 cohort design was used to determine the MTD.


Thirty patients (median age 59 years) were enrolled. The predominant grade >or=3 toxicity was myelosuppression, particularly neutropenia. At dose level 4 (1,000 mg/m(2) gemcitabine), two out of five evaluable patients had a DLT (grade 4 neutropenia >or=7 days). At dose level 3 (800 mg/m(2) gemcitabine), one patient had a DLT (grade 3 neutropenia >or=7 days) among six evaluable patients. Therefore, the MTD and recommended phase II dose was designated as capecitabine 500 mg/m(2) PO BID days 1-14 with 800 mg/m(2) FDR gemcitabine days 1 and 8 infused at 10 mg/m(2) per min on a 21-day cycle. Partial responses occurred in pretreated patients with esophageal, renal cell and bladder carcinomas.


This regimen was well tolerated and may deserve evaluation in advanced gastrointestinal and genitourinary carcinomas.

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