Clinical Cancer Research -- Abstracts: Mace et al. 9 (16): 5829
      HOMEHELPFEEDBACKSUBSCRIPTIONSARCHIVESEARCHTABLE OF CONTENTS
      Cancer ResearchClinical Cancer Research
      Cancer Epidemiology Biomarkers & PreventionMolecular Cancer Therapeutics
      Molecular Cancer ResearchCell Growth & Differentiation


             Full Text of this Article 
             Reprint (PDF) Version of this Article 
             Similar articles found in:
            Clinical Cancer Research Online 
            PubMed 
             PubMed Citation 
             Search PubMed for articles by:
             Mace, J. R. || Baker, L. H. 
             Alert me when: 
            new articles cite this article

             Download to Citation Manager 

Clinical Cancer Research Vol. 9, 5829-5834, December 1, 2003
© 2003 American Association for Cancer Research 



      Clinical Trials

Crossover Randomized Comparison of Intravenous versus Intravenous/Oral Mesna in 
Soft Tissue Sarcoma Treated with High-Dose Ifosfamide 
Joseph R. Mace1, Mary L. Keohan2, Heinz Bernardy3, Klaus Junge3, Georg Niebch3, 
Peter Romeis3, Aangelika Thoma3, Thomas Wagner4, Udo Mueller3, George Demetri5 
and Laurence H. Baker1 
1 Division of Hematology/Oncology, University of Michigan Comprehensive Cancer 
Center, Ann Arbor, Michigan;
2 Herbert Irving Comprehensive Cancer Center, Columbia University, New York, New 
York;
3 Biometrical Department, ASTA Medica AG Frankfurt, Germany;
4 University Hospital Luebeck, Luebeck, Germany; and
5 Division of Medical Oncology, Dana-Farber Cancer Institute, Harvard 
University, Boston, Massachusetts 
ABSTRACT
Purpose: We conducted our study to determine the pharmacokinetics (PK) and 
clinical efficacy of oral mesna in patients receiving ifosfamide for soft tissue 
sarcoma. 
Experimental Design: Seventeen patients were enrolled in a randomized 
prospective Phase I/II study. Seventeen patients were exposed to study 
medication. Ifosfamide was given at a dose of 2 g/m2/day for 5 days on a 21-day 
cycle. Before the first cycle, all patients were randomized onto a crossover 
design and received either the approved i.v. or i.v./oral mesna regimen, with 
crossover for the second cycle of chemotherapy. The i.v. mesna regimen consisted 
of dosings (20% ifosfamide dose) at 0, 4, and 8 h. The i.v./oral arm consisted 
of an i.v. mesna dosing (20% ifosfamide dose) at 0 h, followed by oral tablet 
dosing (40% ifosfamide dose) at 2 and 6 h. In-patient clinical monitoring and 
phlebotomy and urine sampling for mesna, dimesna, and ifosfamide PK were 
performed on all chemotherapy days. 
Results: Thirteen patients were evaluable for PK and 17 for efficacy and 
toxicity. No significant differences were detected in the plasma PK of the 
concomitantly infused ifosfamide. Rates of hemorrhagic cystitis were similar 
across mesna schedules. 
Four of 10 evaluable patients demonstrated objective response. 
Conclusion: On the basis of our study, an i.v./oral mesna regimen is at least as 
uroprotective as the approved i.v. regimen. The i.v./oral regimen will improve 
patient tolerance and convenience, allow for a reduction in elective 
hospitalizations for ifosfamide chemotherapy, reduce the potential morbidity 
associated with inpatient administration of chemotherapy, and likely result in 
decreased costs of care. 







      HOMEHELPFEEDBACKSUBSCRIPTIONSARCHIVESEARCHTABLE OF CONTENTS
      Cancer ResearchClinical Cancer Research
      Cancer Epidemiology Biomarkers & PreventionMolecular Cancer Therapeutics
      Molecular Cancer ResearchCell Growth & Differentiation
Copyright © 2003 by the American Association for Cancer Research. 