Cancer Chemotherapy and Pharmacology

, Volume 64, Issue 1, pp 45–51

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
Original Article

DOI: 10.1007/s00280-008-0844-1

Cite this article as:
Attia, S., Morgan-Meadows, S., Holen, K.D. et al. Cancer Chemother Pharmacol (2009) 64: 45. doi:10.1007/s00280-008-0844-1

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.

Keywords

Capecitabine Gemcitabine Phase I Fixed-dose rate 

Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • Steven Attia
    • 1
  • Sherry Morgan-Meadows
    • 2
  • Kyle D. Holen
    • 1
  • Howard H. Bailey
    • 1
  • Jens C. Eickhoff
    • 1
  • William R. Schelman
    • 1
  • Anne M. Traynor
    • 1
  • Daniel L. Mulkerin
    • 1
  • Toby C. Campbell
    • 1
  • Thomas A. McFarland
    • 1
  • Michael S. Huie
    • 1
  • James F. Cleary
    • 1
  • Amye J. Tevaarwerk
    • 1
  • Dona B. Alberti
    • 1
  • George Wilding
    • 1
  • Glenn Liu
    • 1
  1. 1.University of Wisconsin Paul P. Carbone Comprehensive Cancer Center MadisonMadisonUSA
  2. 2.Gulf Coast Minority-Based Clinical Oncology ProgramMobileUSA

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