Phase II trial of gemcitabine (2,2′-difiuorodeoxycytidine) in patients with adenocarcinoma of the pancreas Journal Article
| Authors: | Casper, E. S.; Green, M. R.; Kelsen, D. P.; Heelan, R. T.; Brown, T. D.; Flombaum, C. D.; Trochanowski, B.; Tarassoff, P. G. |
| Article Title: | Phase II trial of gemcitabine (2,2′-difiuorodeoxycytidine) in patients with adenocarcinoma of the pancreas |
| Abstract: | Gemcitabine is a novel nucleoside analog which demonstrated a broad spectrum of preclinical acitivity in solid tumor models, and responses in patients with pancreas cancer during phase I evaluation. Patients with measurable adenocarcinoma of the pancreas who had received no previous chemotherapy were eligible for this multicenter phase II clinical trial. Gemcitabine 800 mg/m2 was administered intravenously weekly for 3 consecutive weeks, followed by one week rest, every 4 weeks. Forty-four patients entered the trial; 35 had at least 2 cycles of therapy. Partial response was observed in 5 patients (11%, estimated 95% confidence interval 2-20%), with a median duration of 13 months. All responding patients had stabilization or improvement in performance status. Fourteen patients had stable disease of 4 or more months. The median WBC nadir was 3.8 × 103/μl (range 1.6-9.3) and the median absolute neutrophil (ANC) nadir was 2.0 × 103/μl (range 0.4-7.2). Thrombocytopenia - 100.0 × 103/μl was observed in 15 patients; the median platelet nadir was 123.0 (range 30.0-245.0). All patients experienced a mild to moderate flu-like syndrome. In addition, one patient had a mild hemolytic-uremic syndrome which appeared related to gemcitabine therapy. Gemcitabine demonstrated marginal activity in this resistant neoplasm, without excessive toxicity. Further evaluation, including the use of more intense dosing and/or combination therapy, is warranted. © 1994 Kluwer Academic Publishers. |
| Keywords: | adult; cancer chemotherapy; clinical article; aged; aged, 80 and over; clinical trial; skin toxicity; gemcitabine; pancreatic neoplasms; adenocarcinoma; pancreas; phase 2 clinical trial; bone marrow suppression; antimetabolites, antineoplastic; thrombocytopenia; multicenter study; drug response; pancreas adenocarcinoma; leukocyte count; deoxycytidine; phase ii; hemolytic uremic syndrome; intravenous drug administration; injections, intravenous; middle age; drug evaluation; human; male; female; priority journal; article; support, non-u.s. gov't; 2,2′-difluorodeoxycytidme |
| Journal Title: | Investigational New Drugs |
| Volume: | 12 |
| Issue: | 1 |
| ISSN: | 0167-6997 |
| Publisher: | Springer |
| Date Published: | 1994-03-01 |
| Start Page: | 29 |
| End Page: | 34 |
| Language: | English |
| DOI: | 10.1007/bf00873232 |
| PROVIDER: | scopus |
| PUBMED: | 7960602 |
| DOI/URL: | |
| Notes: | Export Date: 14 January 2019 -- Article -- Source: Scopus |
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