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Annals of Oncology 14:580-585, 2003
© 2003 European Society for Medical Oncology

Original Paper

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

S. R. Alberts1,+, P. M. Townley2, R. M. Goldberg1, S. S. Cha1, D. J. Sargent1, D. F. Moore3, J. E. Krook4, H. C. Pitot1, T. R. Fitch5, M. Wiesenfeld6 and J. A. Mailliard2

1 Mayo Clinic and Mayo Foundation, Rochester, MN; 2 Missouri Valley Cancer Consortium, Omaha, NE; 3 Wichita Community Clinical Oncology Program, Wichita, KS; 4 Duluth Community Clinical Oncology Program, Duluth, MN; 5 Scottsdale Community Clinical Oncology Program, Scottsdale, AZ; 6 Cedar Rapids Oncology Project Community Clinical Oncology Program, Cedar Rapids, IA, USA

Received 30 September 2002; revised 25 November 2002; accepted 13 January 2003

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/m2 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.

Key words: gemcitabine, oxaliplatin, pancreatic cancer, phase II trial


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