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Phase II study of gemcitabine, 5-fluorouracil, and leucovorin in patients with pancreatic cancer.
- Source :
-
Seminars in oncology [Semin Oncol] 2001 Jun; Vol. 28 (3 Suppl 10), pp. 44-9. - Publication Year :
- 2001
-
Abstract
- The primary goal of this phase II study was to determine the efficacy of gemcitabine (Gemzar; Eli Lilly and Company, Indianapolis, IN) plus 5-fluorouracil in patients with pancreatic cancer. Eligibility criteria included nonresectable locally advanced or metastatic pancreatic adenocarcinoma and measurable disease. Gemcitabine at 1,000 mg/m(2) and leucovorin at 20 mg/m(2) were administered intravenously 30 minutes before 5-fluorouracil 600 mg/m(2), weekly for 3 of every 4 weeks. Twenty nine patients were enrolled. The overall response rate was 21% (95% confidence interval: 8% to 40%), consisting of one complete response and five partial responses; 16 patients (55%) had stable disease. Median survival was 8.4 months (95% confidence interval: 2.6 to 14.2), and actuarial 1-year survival was 36%. Neutropenia (grade 3 only) was reported in 3.4% of patients, but was generally of short duration. No thrombocytopenia or evidence of cumulative myelosuppression was observed. The only significant nonhematologic events were grade 3 diarrhea and alopecia (both 3.4%). Gemcitabine plus 5-fluorouracil is active and well tolerated compared with results reported for each of these single agents. Thus, this combination justifies future comparative clinical trials. Semin Oncol 28 (suppl 10):44-49.<br /> (Copyright 2001 by W.B. Saunders Company.)
Details
- Language :
- English
- ISSN :
- 0093-7754
- Volume :
- 28
- Issue :
- 3 Suppl 10
- Database :
- MEDLINE
- Journal :
- Seminars in oncology
- Publication Type :
- Academic Journal
- Accession number :
- 11510033
- Full Text :
- https://doi.org/10.1053/sonc.2001.23807