OBJECTIVES: This is a Phase II group-wide study of the Gynecologic Oncology Group to determine the toxicity and objective response rate of trimetrexate (TMTX) in patients with advanced, persistent, or recurrent mixed mesodermal tumors of the uterus who have failed higher priority treatment protocols. METHODS: TMTX was administered orally at a dose of 5 mg/m(2) BID for 5 days and repeated in 14 days. The maximum total dose was 50 mg/m(2)/week given every other week. The minimum treatment period was one course. Patients who had a complete response, partial response, or stable disease were continued on treatment for at least three courses. RESULTS: Twenty-eight patients were entered into the study. Three patients were ineligible based on review of pathologic materials. Twenty-five patients were evaluable for toxicity, and 21 were evaluable for response, as 4 patients did not complete one course of therapy. Eleven patients had heterologous mixed mesodermal tumor (MMT) and 10 had homologous MMT. Of the 25 evaluable for toxicity, one patient had grade 4 platelet toxicity. No patient had grade 4 neutropenia, while 4 patients had grade 3 decrease in absolute neutrophil count. One patient had grade 3 gastrointestinal toxicity, while 2 had grade 4 toxicity. There were no complete responses noted and only one partial response, for an overall response rate of 4.8%. The duration of the partial response was 15.2 months. CONCLUSION: Oral TMTX has insignificant activity in the treatment of advanced, persistent, and recurrent uterine MMT at the dose and schedule administered. (c) 2002 Elsevier Science (USA).
OBJECTIVES: This is a Phase II group-wide study of the Gynecologic Oncology Group to determine the toxicity and objective response rate of trimetrexate (TMTX) in patients with advanced, persistent, or recurrent mixed mesodermal tumors of the uterus who have failed higher priority treatment protocols. METHODS:TMTX was administered orally at a dose of 5 mg/m(2) BID for 5 days and repeated in 14 days. The maximum total dose was 50 mg/m(2)/week given every other week. The minimum treatment period was one course. Patients who had a complete response, partial response, or stable disease were continued on treatment for at least three courses. RESULTS: Twenty-eight patients were entered into the study. Three patients were ineligible based on review of pathologic materials. Twenty-five patients were evaluable for toxicity, and 21 were evaluable for response, as 4 patients did not complete one course of therapy. Eleven patients had heterologous mixed mesodermal tumor (MMT) and 10 had homologous MMT. Of the 25 evaluable for toxicity, one patient had grade 4 platelet toxicity. No patient had grade 4 neutropenia, while 4 patients had grade 3 decrease in absolute neutrophil count. One patient had grade 3 gastrointestinal toxicity, while 2 had grade 4 toxicity. There were no complete responses noted and only one partial response, for an overall response rate of 4.8%. The duration of the partial response was 15.2 months. CONCLUSION: Oral TMTX has insignificant activity in the treatment of advanced, persistent, and recurrent uterine MMT at the dose and schedule administered. (c) 2002 Elsevier Science (USA).
Authors: Matthew A Powell; Virginia L Filiaci; Peter G Rose; Robert S Mannel; Parviz Hanjani; Koen Degeest; Brigitte E Miller; Nobuyuki Susumu; Frederick R Ueland Journal: J Clin Oncol Date: 2010-04-26 Impact factor: 44.544
Authors: Carolyn K McCourt; Wei Deng; Don S Dizon; Heather A Lankes; Michael J Birrer; Michele M Lomme; Matthew A Powell; James E Kendrick; Joel N Saltzman; David Warshal; Meaghan E Tenney; David M Kushner; Carol Aghajanian Journal: Gynecol Oncol Date: 2016-10-28 Impact factor: 5.482
Authors: Khadra Galaal; Esther van der Heijden; Keith Godfrey; Raj Naik; Ali Kucukmetin; Andrew Bryant; Nagindra Das; Alberto D Lopes Journal: Cochrane Database Syst Rev Date: 2013-02-28