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Annals of Oncology 13:553-557, 2002
© 2002 European Society for Medical Oncology

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

S. R. Alberts1,+, P. M. Townley2, R. M. Goldberg1, S. S. Cha1, D. F. Moore3, J. E. Krook4, H. C. Pitot1, T. R. Fitch5, M. Wiesenfeld6, J. A. Mailliard7 and D. J. Sargent1,§

1Mayo Clinic and Mayo Foundation, Rochester, MN; 2Missouri Valley Cancer Consortium, Omaha, NE; 3Wichita Community Clinical Oncology Program, Wichita, KS; 4Duluth CCOP, Duluth, MN; 5Scottsdale CCOP, Scottsdale, AZ; 6Cedar Rapids Oncology Project CCOP, 7Cedar Rapids, IA, USA

Received 29 May 2001; revised 10 September 2001; accepted 25 September 2001.

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.

Key words: gemcitabine, oxaliplatin, pancreatic cancer, phase I


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