Dose-escalation study of fixed-dose rate gemcitabine combined with capecitabine in advanced solid malignancies |
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Authors: | Steven Attia Sherry Morgan-Meadows Kyle D. Holen Howard H. Bailey Jens C. Eickhoff William R. Schelman Anne M. Traynor Daniel L. Mulkerin Toby C. Campbell Thomas A. McFarland Michael S. Huie James F. Cleary Amye J. Tevaarwerk Dona B. Alberti George Wilding Glenn Liu |
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Affiliation: | (1) University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, 600 Highland Avenue, Box 5669, Madison, WI 53792, USA;(2) Gulf Coast Minority-Based Clinical Oncology Program, Mobile, AL 36607, USA |
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Abstract: | Purpose To define dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of capecitabine with fixed-dose rate (FDR) gemcitabine. Methods Eligible adults (advanced solid tumor; performance status ≤2) received capecitabine 500 mg/m2 PO BID days 1–14 and FDR gemcitabine (400–1,000 mg/m2 escalated by 200 mg/m2 increments) at 10 mg/m2/min days 1 and 8 on a 21-day cycle. A traditional 3 + 3 cohort design was used to determine the MTD. Results Thirty patients (median age 59 years) were enrolled. The predominant grade ≥3 toxicity was myelosuppression, particularly neutropenia. At dose level 4 (1,000 mg/m2 gemcitabine), two out of five evaluable patients had a DLT (grade 4 neutropenia ≥7 days). At dose level 3 (800 mg/m2 gemcitabine), one patient had a DLT (grade 3 neutropenia ≥7 days) among six evaluable patients. Therefore, the MTD and recommended phase II dose was designated as capecitabine 500 mg/m2 PO BID days 1–14 with 800 mg/m2 FDR gemcitabine days 1 and 8 infused at 10 mg/m2 per min on a 21-day cycle. Partial responses occurred in pretreated patients with esophageal, renal cell and bladder carcinomas. Conclusions This regimen was well tolerated and may deserve evaluation in advanced gastrointestinal and genitourinary carcinomas. The results of this research appeared as abstract ID 13509 at the 2008 American Association of Clinical Oncology meeting in Chicago, IL, USA. |
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Keywords: | Capecitabine Gemcitabine Phase I Fixed-dose rate |
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