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

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

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)45-51
Number of pages7
JournalCancer chemotherapy and pharmacology
Issue number1
StatePublished - Jun 2009


  • Capecitabine
  • Fixed-dose rate
  • Gemcitabine
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)


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