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Annals of Oncology Advance Access published online on June 4, 2008
Annals of Oncology, doi:10.1093/annonc/mdn375
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Phase I study of biweekly oxaliplatin, gemcitabine and capecitabine in patients with advanced upper gastrointestinal malignancies

B. R. Tan1,*, W. S. Brenner2, J. Picus1, S. Marsh3, F. Gao4, C. Fournier1, P. M. Fracasso5, J. James1, J. L. Yen-Revollo6 and H. L. Mcleod6

1 Division of Medical Oncology, Washington University School of Medicine, St Louis
2 Center for Hematology/Oncology, Boynton Beach
3 Division of Molecular Oncology
4 Division of Biostatistics, Washington University School of Medicine, St Louis
5 Division of Hematology/Oncology, University of Virginia, Charlottesville
6 UNC Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, USA

* Correspondence to: Dr B. R. Tan, Washington University School of Medicine, 660 South Euclid Avenue, Box 8056, St Louis, MO 63110, USA. Tel: +314-362-5737; Fax: +314-362-7086; E-mail: btan{at}im.wustl.edu

Background: Oxaliplatin, gemcitabine and capecitabine are all active agents against upper gastrointestinal and pancreaticobiliary cancers.

Patients and methods: Patients with upper gastrointestinal malignancies treated with 0–2 prior chemotherapy regimens received oxaliplatin (85–100 mg/m2) as a 2-h i.v. infusion with gemcitabine (800–1000 mg/m2) at a constant rate i.v. infusion (CI) of 10 mg/m2/min on days 1 and 15 of a 28-day cycle. Capecitabine (600–800 mg/m2) was administered orally twice a day on days 1–7 and 15–21. A three per cohort dose escalation schema was used to determine the maximum tolerated dose (MTD) and the dose-limiting toxic effects (DLTs) of this combination regimen.

Results: Thirty patients with advanced upper gastrointestinal malignancies were enrolled. The MTD was defined as oxaliplatin 100 mg/m2 i.v. over 2 h plus gemcitabine 800 mg/m2 i.v. at a CI of 10 mg/m2/min on days 1 and 15 with capecitabine 800 mg/m2 p.o. b.i.d. days 1–7 and 15–21 of a 29-day cycle. DLTs include grade 3 fatigue and grade 3 dyspnea. One complete and two partial responses were observed.

Conclusions: This biweekly schedule of oxaliplatin, gemcitabine and capecitabine is tolerable and warrants further investigation in biliary and pancreatic malignancies.

Capecitabine, gemcitabine, oxaliplatin, upper gastrointestinal malignancies

Received for publication April 1, 2008. Revision received May 1, 2008. Accepted for publication May 2, 2008.


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