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

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 > or =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/m(2), respectively, showed moderate activity in patients with pancreatic ACA. Based on the results of this study further evaluation of this combination is warranted.

• Authors: S R Alberts, P M Townley, R M Goldberg, S S Cha, D J Sargent, D F Moore, J E Krook, H C Pitot, T R Fitch, M Wiesenfeld, J A Mailliard
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 14 Issue 4 Pg. 580-5 (Apr 2003) ISSN: 0923-7534 [Print] England
• PMID: 12649105 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Deoxycytidine
• Gemcitabine

Topics

• Adenocarcinoma (drug therapy, pathology)
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Disease Progression
• Female
• Hemolytic-Uremic Syndrome (chemically induced)
• Humans
• Infusions, Intravenous
• Male
• Middle Aged
• Neoplasm Metastasis
• Organoplatinum Compounds (administration & dosage)
• Oxaliplatin
• Pancreatic Neoplasms (drug therapy, pathology)
• Survival
• Treatment Outcome
• Gemcitabine