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Annals of Oncology 14:1682-1687, 2003
© 2003 European Society for Medical Oncology

Original Paper

Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine (FOG regimen) in patients with solid tumors

S. Goel1, A. Bulgaru1, H. Hochster3, S. Wadler1, W. Zamboni4, M. Egorin4, P. Ivy5, L. Leibes3, F. Muggia3, G. Lockwood6, E. Harvey6, G. Renshaw7 and S. Mani1,2,+

1 Department of Oncology, Albert Einstein Comprehensive Cancer Center and Montefiore Medical Center, New York, NY; 2 Albert Einstein College of Medicine, New York, NY; 3 New York University Comprehensive Cancer Center, New York, NY; 4 University of Pittsburgh Cancer Institute, Pittsburgh, PA; 5 National Cancer Institute, Bethesda, MD; 6 Sanofi-Synthelabo Inc., Malvern, PA; 7 Eli-Lilly, Indianapolis, IN, USA

Received 12 May 2003; accepted 7 August 2003

Background:

The aim of this study was to determine the maximum tolerated dose, recommended phase II dose (RPTD) and toxicities of the FOG regimen (infusional 5-fluorouracil, oxaliplatin, gemcitabine).

Patients and methods:

Patients with advanced solid tumors were treated in an accelerated titration scheme. 5-Fluorouracil was administered intravenously at 200 mg/m2/day for 14 days and repeated every 21 days (one cycle). Gemcitabine was administered on days 1 and 8 over 30 min at 450–650 mg/m2. Oxaliplatin was administered on day 1 over 2 h at 85–130 mg/m2. For cycles 1, 3 and beyond, gemcitabine followed oxaliplatin; for cycle 2, gemcitabine preceded oxaliplatin.

Results:

Forty-five and 39 patients were assessable for toxicity and response, respectively. Cycle 1 dose-limiting toxicities (DLT) included neutropenia, thrombocytopenia and diarrhea. No DLT was observed in cycle 1 at the first four dose levels (DL). At DL-5, two of four (50%) patients experienced DLT in cycle 1. Expanding DL-4, nine of 26 (35%) patients experienced DLT in cycle 1. Because recurrent grade 3 toxicities were observed in three of six (50%) patients at DL-3, DL-2 was considered the RPTD. At the RPTD, three patients had a partial response (response rate 23%).

Conclusions:

The RPTD for the 5-fluorouracil–oxaliplatin–gemcitabine combination is 200/100/450 mg/m2. This novel regimen has demonstrated activity in advanced solid tumors and merits further investigation.

Key words: 5-fluorouracil, gemcitabine, oxaliplatin, phase I, solid tumors


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