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Title: A phase I study of TNP-470 administered to patients with advanced squamous cell cancer of the cervix
Authors: Andrzej P. Kudelka
Tally Levy
Claire F. Verschraegen
Creighton L. Edwards
Surintip Piamsomboon
Wichai Termrungruanglert
Ralph S. Freedman
Alan L. Kaplan
Dirk G. Kieback
Christina A. Meyers
Kurt A. Jaeckle
Evelyne Loyer
Melissa Steger
Rosario Mante
Giora Mavligit
Anthony Killian
Rosa A. Tang
Jordon U. Gutterman
John J. Kavanagh
University of Texas MD Anderson Cancer Center
Baylor College of Medicine
Mahidol University
Chulalongkorn University
TAP Holdings
University of Texas System
Keywords: Biochemistry, Genetics and Molecular Biology;Medicine
Issue Date: 1-Sep-1997
Citation: Clinical Cancer Research. Vol.3, No.9 (1997), 1501-1505
Abstract: A Phase I study of the novel angiongenesis inhibitor TNP-470 was performed. Patients with inoperable recurring or metastatic squamous cell cancer of the cervix with evaluable disease, no coagulopathy, and adequate renal, hepatic, and hematological function were eligible. One course of treatment consisted of an i.v. infusion of TNP-470 over 60 min every other day for 28 days, followed by a 14-day rest period. The starting dose was 9.3 mg/m2. Eighteen evaluable patients were treated, with a median age of 48 years (range 27-55) and performance status Zubrod 1 (range 0-2). Grade 3 neurotoxicities consisting of weakness, nystagmus, diplopia, and ataxia were encountered in two patients receiving the 71.2 mg/m2dose. An intermediate dose level of 60 mg/m2was evaluated and found to be well tolerated by three patients. Only one patient experienced grade 3 nausea on the 60 mg/m2dose level. No myelosuppression, retinal hemorrhage, weight loss, or significant alopecia were observed. One patient had a complete response, which continues for 26 months, and three patients with initially progressive disease stage had stable disease for 5, 7.7, and 19+ months. Other Phase I studies, including over 200 patients, were performed concurrently with this study. Based on this experience, the dose of TNP- 470 recommended for further studies is 60 mg/m2as a 60-min i.v. infusion every Monday, Wednesday, and Friday. Neurotoxicity was dose limiting, but appears to be reversible. Otherwise, the treatment was well tolerated. The drug may be active in squamous cell cancer of the cervix. Further studies of TNP-470 in squamous cell cancer of the cervix are warranted.
ISSN: 10780432
Appears in Collections:Scopus 1991-2000

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