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Cancer Investigation Volume 27, 2009 - Issue 2
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ORIGINAL ARTICLES Clinical Translational Therapeutics

Capecitabine, Oxaliplatin and Radiotherapy: A Phase IB Neoadjuvant Study for Esophageal Cancer with Gene Expression Analysis

Milind M. Javle Department of Gastrointestinal Medical Oncology, UT-MD Anderson Cancer Institute, Houston, Texas, USA; Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Gary Yang Department Radiation, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Chumy E. Nwogu Department of Surgery, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Gregory E. Wilding Department of Biostatistics, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Linda O'Malley Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Sanjay Vinjamaram Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Michael D. Schiff Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Hector R. Nava Department of Surgery, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Charles LeVea Department of Pathology, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Kimberly R. Clark Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Joshua D. Prey Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA
,
Patrick F. Smith Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA; Roche Pharmaceuticals, Nutley, New Jersey, USA
&
Lakshmi Pendyala Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA
 show all
Pages 193-200 | Published online: 11 Jun 2009
 
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Abstract

Purpose: To determine the maximal tolerated dose of capecitabine with oxaliplatin + radiotherapy in a phase I study of localized esophageal cancer. Patients and Methods: Oxaliplatin (85 mg/m2) administered on days 1, 15, and 29. Capecitabine administered twice daily 5 days weekly; dose levels (DL) were 1, 1000; 2, 1250; and 3, 1500 mg/m2 with 50.4 Gy radiation. Results: Dose-limiting toxicity was reached at DL 3. Carboxylesterase expression in day 2 tumor specimens and induction correlated with response (p ≤ 0.05). Conclusion: The maximal tolerated dose was 85 mg/m2 of oxaliplatin, 1,250 mg/m2/day of capecitabine, and 50.4 Gy of radiation.

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