Gemcitabine and oxaliplatin for metastatic pancreatic adenocarcinoma: A North Central Cancer Treatment Group phase II study

Steven Robert Alberts, P. M. Townley, R. M. Goldberg, S. S. Cha, D. J. Sargent, D. F. Moore, J. E. Krook, Henry Clement Pitot, T. R. Fitch, M. Wiesenfeld, J. A. Mailliard

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Abstract

Background: This study was performed to determine the efficacy 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 phase II study of gemcitabine and oxaliplatin. Oxaliplatin was given i.v. on day 1 and gemcitabine i.v. on days 1 and 8 of a 3-week cycle. The primary end point of the trial was 6-month survival. Secondary end points included response rate, overall survival, median time to progression and toxicity. Results: A total of 47 patients were enrolled, 46 of whom were evaluable. Of those patients assessed for the primary end point 50% lived for ≥6 months. The median time to progression was 4.53 months. Five confirmed responses were seen with a median duration of response of 2.7 months. Overall, the treatment was well tolerated. However, one patient died as a result of treatment-related hemolytic uremic syndrome. Conclusions: Gemcitabine and oxaliplatin, at doses of 1000 mg/m 2 and 100 mg/m2, respectively, showed moderate activity in patients with pancreatic ACA. Based on the results of this study further evaluation of this combination is warranted.

Original languageEnglish (US)
Pages (from-to)580-585
Number of pages6
JournalAnnals of Oncology
Volume14
Issue number4
DOIs
StatePublished - Apr 2003

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oxaliplatin
gemcitabine
Adenocarcinoma
Neoplasms
Therapeutics
Hemolytic-Uremic Syndrome

Keywords

  • Gemcitabine
  • Oxaliplatin
  • Pancreatic cancer
  • Phase II trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Gemcitabine and oxaliplatin for metastatic pancreatic adenocarcinoma : A North Central Cancer Treatment Group phase II study. / Alberts, Steven Robert; Townley, P. M.; Goldberg, R. M.; Cha, S. S.; Sargent, D. J.; Moore, D. F.; Krook, J. E.; Pitot, Henry Clement; Fitch, T. R.; Wiesenfeld, M.; Mailliard, J. A.

In: Annals of Oncology, Vol. 14, No. 4, 04.2003, p. 580-585.

Research output: Contribution to journalArticle

Alberts, SR, Townley, PM, Goldberg, RM, Cha, SS, Sargent, DJ, Moore, DF, Krook, JE, Pitot, HC, Fitch, TR, Wiesenfeld, M & Mailliard, JA 2003, 'Gemcitabine and oxaliplatin for metastatic pancreatic adenocarcinoma: A North Central Cancer Treatment Group phase II study', Annals of Oncology, vol. 14, no. 4, pp. 580-585. https://doi.org/10.1093/annonc/mdg170
Alberts, Steven Robert ; Townley, P. M. ; Goldberg, R. M. ; Cha, S. S. ; Sargent, D. J. ; Moore, D. F. ; Krook, J. E. ; Pitot, Henry Clement ; Fitch, T. R. ; Wiesenfeld, M. ; Mailliard, J. A. / Gemcitabine and oxaliplatin for metastatic pancreatic adenocarcinoma : A North Central Cancer Treatment Group phase II study. In: Annals of Oncology. 2003 ; Vol. 14, No. 4. pp. 580-585.
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AB - Background: This study was performed to determine the efficacy 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 phase II study of gemcitabine and oxaliplatin. Oxaliplatin was given i.v. on day 1 and gemcitabine i.v. on days 1 and 8 of a 3-week cycle. The primary end point of the trial was 6-month survival. Secondary end points included response rate, overall survival, median time to progression and toxicity. Results: A total of 47 patients were enrolled, 46 of whom were evaluable. Of those patients assessed for the primary end point 50% lived for ≥6 months. The median time to progression was 4.53 months. Five confirmed responses were seen with a median duration of response of 2.7 months. Overall, the treatment was well tolerated. However, one patient died as a result of treatment-related hemolytic uremic syndrome. Conclusions: Gemcitabine and oxaliplatin, at doses of 1000 mg/m 2 and 100 mg/m2, respectively, showed moderate activity in patients with pancreatic ACA. Based on the results of this study further evaluation of this combination is warranted.

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