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Phase I trial of twice-weekly gemcitabine and concurrent radiation in patients with advanced pancreatic cancer.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 1999 Jul; Vol. 17 (7), pp. 2208-12. - Publication Year :
- 1999
-
Abstract
- Purpose: To determine the maximum-tolerated dose, dose-limiting toxicities, and potential antitumor activity of twice-weekly gemcitabine and concurrent radiation in patients with locally advanced pancreatic cancer.<br />Patients and Methods: Nineteen patients with histologically confirmed adenocarcinoma of the pancreas were studied at the Wake Forest University Baptist Medical Center and the University of North Carolina at Chapel Hill. The initial dose of gemcitabine was 20 mg/m(2) by 30-minute intravenous infusion each Monday and Thursday for 5 weeks concurrent with 50.4 Gy of radiation to the pancreas. Gemcitabine doses were escalated in 20-mg/m(2) increments in successive cohorts of three to six additional patients until dose-limiting toxicity was observed.<br />Results: The dose-limiting toxicities at 60 mg/m(2) given twice-weekly were nausea/vomiting, neutropenia, and thrombocytopenia. Twice-weekly gemcitabine at a 40-mg/m(2) dose was well tolerated. Of the eight patients eligible for a minimum follow-up of 12 months, three remain alive, one of whom has no evidence of disease progression.<br />Conclusion: A dose of twice-weekly gemcitabine at 40 mg/m(2) produced mild thrombocytopenia, neutropenia, nausea, and vomiting when delivered with concurrent radiation to the upper abdomen in patients with advanced pancreatic cancer. These data suggest this regimen is well tolerated and may possess significant activity. These data and other observations have resulted in a phase II Cancer and Leukemia Group B study to ascertain the efficacy of this treatment regimen in patients with locally advanced pancreatic cancer.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antimetabolites, Antineoplastic pharmacology
Combined Modality Therapy
Deoxycytidine pharmacology
Deoxycytidine therapeutic use
Dose-Response Relationship, Drug
Humans
Middle Aged
Gemcitabine
Antimetabolites, Antineoplastic therapeutic use
Deoxycytidine analogs & derivatives
Pancreatic Neoplasms drug therapy
Pancreatic Neoplasms radiotherapy
Subjects
Details
- Language :
- English
- ISSN :
- 0732-183X
- Volume :
- 17
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 10561277
- Full Text :
- https://doi.org/10.1200/JCO.1999.17.7.2208