Gemcitabine and oxaliplatin for patients with advanced or metastatic pancreatic cancer: A North Central Cancer Treatment Group (NCCTG) phase I study

S. R. Alberts; P. M. Townley; R. M. Goldberg; S. S. Cha; D. F. Moore; J. E. Krook; H. C. Pitot; T. R. Fitch; M. Wiesenfeld; J. A. Mailliard; D. J. Sargent

doi:10.1093/annonc/mdf062

Gemcitabine and oxaliplatin for patients with advanced or metastatic pancreatic cancer: A North Central Cancer Treatment Group (NCCTG) phase I study

S. R. Alberts, P. M. Townley, R. M. Goldberg, S. S. Cha, D. F. Moore, J. E. Krook, H. C. Pitot, T. R. Fitch, M. Wiesenfeld, J. A. Mailliard, D. J. Sargent

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Abstract

Background: The study was performed to determine the maximum tolerated dose (MTD) of gemcitabine and oxaliplatin in patients with advanced or metastatic pancreatic adenocarcinoma (ACA). Patients and methods: Pancreatic ACA patients, with previously untreated advanced or metastatic disease, were enrolled in a dose escalation study of gemcitabine and oxaliplatin. Oxaliplatin was given intravenously on day 1 and gemcitabine intravenously on days 1 and 8 of a 3-week cycle. Doses of both drugs were increased with sequential cohorts of patients until dose-limiting toxicity (DLT) was observed. Results: A total of 18 patients were enrolled to three dose levels. DLT of neutropenia and a severe infection was noted at a dose of gemcitabine 1250 mg/m² and oxaliplatin 130 mg/m². Hematological toxicity and nausea and vomiting were the most common grade 3/4 toxicities. The MTD, gemcitabine 1000 mg/m² and oxaliplatin 100 mg/m², was well tolerated. Three confirmed responses were seen. Conclusions: The MTD of gemcitabine and oxaliplatin in patients with pancreatic ACA was determined. A phase II study of this combination is ongoing and will be reported separately at a later date.

Original language	English (US)
Pages (from-to)	553-557
Number of pages	5
Journal	Annals of Oncology
Volume	13
Issue number	4
DOIs	https://doi.org/10.1093/annonc/mdf062
State	Published - Apr 2002

Keywords

Gemcitabine
Oxaliplatin
Pancreatic cancer
Phase I

ASJC Scopus subject areas

Hematology
Oncology

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10.1093/annonc/mdf062

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Alberts, S. R., Townley, P. M., Goldberg, R. M., Cha, S. S., Moore, D. F., Krook, J. E., Pitot, H. C., Fitch, T. R., Wiesenfeld, M., Mailliard, J. A., & Sargent, D. J. (2002). Gemcitabine and oxaliplatin for patients with advanced or metastatic pancreatic cancer: A North Central Cancer Treatment Group (NCCTG) phase I study. Annals of Oncology, 13(4), 553-557. https://doi.org/10.1093/annonc/mdf062

Alberts, SR, Townley, PM, Goldberg, RM, Cha, SS, Moore, DF, Krook, JE, Pitot, HC, Fitch, TR, Wiesenfeld, M, Mailliard, JA & Sargent, DJ 2002, 'Gemcitabine and oxaliplatin for patients with advanced or metastatic pancreatic cancer: A North Central Cancer Treatment Group (NCCTG) phase I study', Annals of Oncology, vol. 13, no. 4, pp. 553-557. https://doi.org/10.1093/annonc/mdf062

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title = "Gemcitabine and oxaliplatin for patients with advanced or metastatic pancreatic cancer: A North Central Cancer Treatment Group (NCCTG) phase I study",

abstract = "Background: The study was performed to determine the maximum tolerated dose (MTD) of gemcitabine and oxaliplatin in patients with advanced or metastatic pancreatic adenocarcinoma (ACA). Patients and methods: Pancreatic ACA patients, with previously untreated advanced or metastatic disease, were enrolled in a dose escalation study of gemcitabine and oxaliplatin. Oxaliplatin was given intravenously on day 1 and gemcitabine intravenously on days 1 and 8 of a 3-week cycle. Doses of both drugs were increased with sequential cohorts of patients until dose-limiting toxicity (DLT) was observed. Results: A total of 18 patients were enrolled to three dose levels. DLT of neutropenia and a severe infection was noted at a dose of gemcitabine 1250 mg/m2 and oxaliplatin 130 mg/m2. Hematological toxicity and nausea and vomiting were the most common grade 3/4 toxicities. The MTD, gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2, was well tolerated. Three confirmed responses were seen. Conclusions: The MTD of gemcitabine and oxaliplatin in patients with pancreatic ACA was determined. A phase II study of this combination is ongoing and will be reported separately at a later date.",

keywords = "Gemcitabine, Oxaliplatin, Pancreatic cancer, Phase I",

author = "Alberts, {S. R.} and Townley, {P. M.} and Goldberg, {R. M.} and Cha, {S. S.} and Moore, {D. F.} and Krook, {J. E.} and Pitot, {H. C.} and Fitch, {T. R.} and M. Wiesenfeld and Mailliard, {J. A.} and Sargent, {D. J.}",

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doi = "10.1093/annonc/mdf062",

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T1 - Gemcitabine and oxaliplatin for patients with advanced or metastatic pancreatic cancer

T2 - A North Central Cancer Treatment Group (NCCTG) phase I study

AU - Alberts, S. R.

AU - Townley, P. M.

AU - Goldberg, R. M.

AU - Cha, S. S.

AU - Moore, D. F.

AU - Krook, J. E.

AU - Pitot, H. C.

AU - Fitch, T. R.

AU - Wiesenfeld, M.

AU - Mailliard, J. A.

AU - Sargent, D. J.

PY - 2002/4

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N2 - Background: The study was performed to determine the maximum tolerated dose (MTD) of gemcitabine and oxaliplatin in patients with advanced or metastatic pancreatic adenocarcinoma (ACA). Patients and methods: Pancreatic ACA patients, with previously untreated advanced or metastatic disease, were enrolled in a dose escalation study of gemcitabine and oxaliplatin. Oxaliplatin was given intravenously on day 1 and gemcitabine intravenously on days 1 and 8 of a 3-week cycle. Doses of both drugs were increased with sequential cohorts of patients until dose-limiting toxicity (DLT) was observed. Results: A total of 18 patients were enrolled to three dose levels. DLT of neutropenia and a severe infection was noted at a dose of gemcitabine 1250 mg/m2 and oxaliplatin 130 mg/m2. Hematological toxicity and nausea and vomiting were the most common grade 3/4 toxicities. The MTD, gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2, was well tolerated. Three confirmed responses were seen. Conclusions: The MTD of gemcitabine and oxaliplatin in patients with pancreatic ACA was determined. A phase II study of this combination is ongoing and will be reported separately at a later date.

AB - Background: The study was performed to determine the maximum tolerated dose (MTD) of gemcitabine and oxaliplatin in patients with advanced or metastatic pancreatic adenocarcinoma (ACA). Patients and methods: Pancreatic ACA patients, with previously untreated advanced or metastatic disease, were enrolled in a dose escalation study of gemcitabine and oxaliplatin. Oxaliplatin was given intravenously on day 1 and gemcitabine intravenously on days 1 and 8 of a 3-week cycle. Doses of both drugs were increased with sequential cohorts of patients until dose-limiting toxicity (DLT) was observed. Results: A total of 18 patients were enrolled to three dose levels. DLT of neutropenia and a severe infection was noted at a dose of gemcitabine 1250 mg/m2 and oxaliplatin 130 mg/m2. Hematological toxicity and nausea and vomiting were the most common grade 3/4 toxicities. The MTD, gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2, was well tolerated. Three confirmed responses were seen. Conclusions: The MTD of gemcitabine and oxaliplatin in patients with pancreatic ACA was determined. A phase II study of this combination is ongoing and will be reported separately at a later date.

KW - Gemcitabine

KW - Oxaliplatin

KW - Pancreatic cancer

KW - Phase I

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Gemcitabine and oxaliplatin for patients with advanced or metastatic pancreatic cancer: A North Central Cancer Treatment Group (NCCTG) phase I study

Abstract

Keywords

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