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

Sanjay Goel, A. Bulgaru, H. Hochster, S. Wadler, W. Zamboni, M. Egorin, P. Ivy, L. Leibes, F. Muggia, G. Lockwood, E. Harvey, G. Renshaw, Sridhar Mani

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Abstract

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 investigations.

Original languageEnglish (US)
Pages (from-to)1682-1687
Number of pages6
JournalAnnals of Oncology
Volume14
Issue number11
DOIs
StatePublished - Nov 2003

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oxaliplatin
gemcitabine
Fluorouracil
Neoplasms
Maximum Tolerated Dose
gemcitabine-oxaliplatin regimen
Clinical Studies
Neutropenia
Thrombocytopenia
Diarrhea

Keywords

  • 5-fluorouracil
  • Gemcitabine
  • Oxaliplatin
  • Phase I
  • Solid tumors

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine (FOG regimen) in patients with solid tumors. / Goel, Sanjay; Bulgaru, A.; Hochster, H.; Wadler, S.; Zamboni, W.; Egorin, M.; Ivy, P.; Leibes, L.; Muggia, F.; Lockwood, G.; Harvey, E.; Renshaw, G.; Mani, Sridhar.

In: Annals of Oncology, Vol. 14, No. 11, 11.2003, p. 1682-1687.

Research output: Contribution to journalArticle

Goel, S, Bulgaru, A, Hochster, H, Wadler, S, Zamboni, W, Egorin, M, Ivy, P, Leibes, L, Muggia, F, Lockwood, G, Harvey, E, Renshaw, G & Mani, S 2003, 'Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine (FOG regimen) in patients with solid tumors', Annals of Oncology, vol. 14, no. 11, pp. 1682-1687. https://doi.org/10.1093/annonc/mdg453
Goel, Sanjay ; Bulgaru, A. ; Hochster, H. ; Wadler, S. ; Zamboni, W. ; Egorin, M. ; Ivy, P. ; Leibes, L. ; Muggia, F. ; Lockwood, G. ; Harvey, E. ; Renshaw, G. ; Mani, Sridhar. / Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine (FOG regimen) in patients with solid tumors. In: Annals of Oncology. 2003 ; Vol. 14, No. 11. pp. 1682-1687.
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abstract = "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 investigations.",
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T1 - Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine (FOG regimen) in patients with solid tumors

AU - Goel, Sanjay

AU - Bulgaru, A.

AU - Hochster, H.

AU - Wadler, S.

AU - Zamboni, W.

AU - Egorin, M.

AU - Ivy, P.

AU - Leibes, L.

AU - Muggia, F.

AU - Lockwood, G.

AU - Harvey, E.

AU - Renshaw, G.

AU - Mani, Sridhar

PY - 2003/11

Y1 - 2003/11

N2 - 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 investigations.

AB - 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 investigations.

KW - 5-fluorouracil

KW - Gemcitabine

KW - Oxaliplatin

KW - Phase I

KW - Solid tumors

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