| Phase I trial of strictly time-scheduled gemcitabine and cisplatin with concurrent radiotherapy in patients with locally advanced pancreatic cancer. | |
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MedLine Citation:
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PMID: 12504047 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: Maximal therapeutic gain in xenograft sarcoma and toxicity for jejunal mucosa is time dependent for concurrent gemcitabine and radiotherapy (RT). We used a time-dependent schedule to determine the maximal-tolerated dose and dose-limiting toxicities (DLTs; Grade 4 hematologic or Grade 3 other toxicity). METHODS AND MATERIALS: Patients with pancreatic cancer (n = 33), periampullary carcinoma (n = 1), or bile duct cancer (n = 2) were treated with 3-day conformal RT with 50.4 Gy (tumor, lymphatics) plus a 5.4-Gy boost. Concurrent cisplatin (20 mg/m(2)/d on Days 1-5 and 29-33) and gemcitabine (initially 600 mg/m(2), weekly on Fridays 68 h before RT) were administered. Because of DLT, the doses were reduced to 500 mg/m(2) weekly and then 500, 400, or 300 mg/m(2) on Days 2, 5, 26, 33. RESULTS: DLT occurred at all dose levels of gemcitabine >300 mg/m(2). Fourteen patients were treated at the recommended Phase II dose of gemcitabine (300 mg/m(2)) without DLT. The response to chemoradiation allowed 10 of 30 initially unresectable patients with primary pancreatic carcinoma to undergo radical surgery, including a complete response in 2 cases. CONCLUSIONS: At the recommended Phase II dose, chemoradiation with gemcitabine and cisplatin can be administered safely in pancreatic carcinoma. However, at higher dose levels, toxicity is severe and frequent. Patients with a chance for conversion to resection could benefit from this schedule. |
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Authors:
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Thomas B Brunner; Gerhard G Grabenbauer; Peter Klein; Ulrich Baum; Thomas Papadopoulos; Werner Bautz; Werner Hohenberger; Rolf Sauer |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase I; Journal Article |
Journal Detail:
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Title: International journal of radiation oncology, biology, physics Volume: 55 ISSN: 0360-3016 ISO Abbreviation: Int. J. Radiat. Oncol. Biol. Phys. Publication Date: 2003 Jan |
Date Detail:
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Created Date: 2002-12-30 Completed Date: 2003-01-28 Revised Date: 2006-04-24 |
Medline Journal Info:
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Nlm Unique ID: 7603616 Medline TA: Int J Radiat Oncol Biol Phys Country: United States |
Other Details:
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Languages: eng Pagination: 144-53 Citation Subset: IM |
Affiliation:
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Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. TBrunner@mail.med.upenn.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Antineoplastic Combined Chemotherapy Protocols / adverse effects, therapeutic use* Blood Cells / drug effects, radiation effects Cisplatin / administration & dosage Combined Modality Therapy Deoxycytidine / administration & dosage, analogs & derivatives* Digestive System / drug effects Female Humans Male Maximum Tolerated Dose Middle Aged Pancreatic Neoplasms / mortality, pathology, therapy* Radiotherapy / adverse effects Radiotherapy Dosage |
| Chemical | |
Reg. No./Substance:
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103882-84-4/gemcitabine; 15663-27-1/Cisplatin; 951-77-9/Deoxycytidine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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