| Results of a 2-arm Phase II study of 9-nitrocamptothecin in patients with advanced soft-tissue sarcomas. | |
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MedLine Citation:
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PMID: 12767099 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: The authors conducted a 2-arm Phase II trial of 9-nitrocamptothecin (9-NC), an oral topoisomerase I inhibitor, to define response rates in patients with gastrointestinal (GI) leiomyosarcomas and other soft-tissue sarcomas (STS). METHODS: Patients were required to provide informed consent and have measurable disease, Zubrod performance status < or = 2, and adequate organ function. 9-NC was administered orally at 1.5 mg/m(2) per day x 5 days every week. Response evaluation was performed at 8 weeks, and those with stable or responding disease continued treatment until maximal response was achieved. A total of 56 patients (30 females and 26 males) with a median age of 55 years (range, 19-79 years) were enrolled on the study. Seventeen patients were enrolled on the GI leiomyosarcoma arm; only 1 minor response, lasting < 8 weeks in a patient with liver metastases, was noted, and so this arm was terminated. Thirty-nine patients were entered on the other STS arm. RESULTS: Three patients achieved a partial response (response rate, 8%) for durations of 4, 6, and 13 months, respectively. Fourteen patients had stable disease for a median of 4 months (range, 2-8 months). Two patients died of disease during the first 2 months. Four other patients required hospitalization for nausea, vomiting, and dehydration. Other toxicities included diarrhea (36 patients, 5 with Grade 3 toxicity); fatigue (42 patients, 11 with Grade 3 toxicity); anorexia (32 patients, 1 with Grade 3 toxicity); nausea (37 patients, 2 with Grade 3 toxicity); vomiting (24 patients, 3 with Grade 3 toxicity); neutropenia (14 patients, 5 with Grade 3 toxicity); and thrombocytopenia (16 patients, 5 with Grade 3 or 4 toxicity). CONCLUSIONS: 9-NC is well tolerated but inactive in GI leiomyosarcomas and has minimal activity in previously treated patients with STS. |
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Authors:
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Shreyaskumar R Patel; Jennifer Beach; Nicholas Papadopoulos; M Andrew Burgess; Jonathan Trent; Jan Jenkins; Robert S Benjamin |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Cancer Volume: 97 ISSN: 0008-543X ISO Abbreviation: Cancer Publication Date: 2003 Jun |
Date Detail:
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Created Date: 2003-05-26 Completed Date: 2003-06-20 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0374236 Medline TA: Cancer Country: United States |
Other Details:
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Languages: eng Pagination: 2848-52 Citation Subset: AIM; IM |
Copyright Information:
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Copyright 2003 American Cancer Society. |
Affiliation:
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Department of Sarcoma Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston 77030, USA. spatel@mdanderson.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Oral Adult Aged Antineoplastic Agents / administration & dosage, therapeutic use*, toxicity Camptothecin / administration & dosage, analogs & derivatives*, therapeutic use*, toxicity DNA Topoisomerases, Type I / antagonists & inhibitors Female Gastrointestinal Neoplasms / drug therapy Humans Leiomyosarcoma / drug therapy Male Middle Aged Sarcoma / drug therapy*, mortality Soft Tissue Neoplasms / drug therapy*, mortality Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 104195-61-1/9-nitrocamptothecin; 7689-03-4/Camptothecin; EC 5.99.1.2/DNA Topoisomerases, Type I |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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