PURPOSE: This phase I biochemical modulation study evaluated the maximum-tolerated dose (MTD), toxicity, and effectiveness of the combination of folinic acid (FA)/fluorouracil (5-FU) followed by escalated dose levels of gemcitabine (FFG) in patients with advanced solid tumors. PATIENTS AND METHODS: Patients were refractory to primary treatment and/or without effective treatment options. Twenty-eight patients received an intravenous (IV) infusion of FA 100 mg/m(2) over 1 hour and a 5-FU 450 mg/m(2) IV bolus in the middle of the FA infusion. After the FA infusion, gemcitabine was administered at a steady rate of infusion of 10 mg/m(2)/min over initially 30 minutes and with increases of an additional 15 minutes at each given level. One cycle consisted of six weekly treatments followed by a 2-week rest. RESULTS: The MTD of gemcitabine was established at 900 mg/m(2) given over 90 minutes. Eight patients of 21 with metastatic colorectal cancer achieved responses (one complete response; seven partial responses), for a response rate of 38%. Responses were seen across the gemcitabine doses of 300 to 900 mg/m(2). One patient had prior treatment with FA/5-FU for advanced disease. Patients with colorectal carcinoma had a median survival of 18 months, and the patient with lung carcinoma has been alive for 24+ months. CONCLUSION: The combination chemotherapy of FFG was well tolerated and may benefit patients with advanced colorectal carcinoma. A phase II evaluation in this patient population is in progress.
PURPOSE: This phase I biochemical modulation study evaluated the maximum-tolerated dose (MTD), toxicity, and effectiveness of the combination of folinic acid (FA)/fluorouracil (5-FU) followed by escalated dose levels of gemcitabine (FFG) in patients with advanced solid tumors. PATIENTS AND METHODS: Patients were refractory to primary treatment and/or without effective treatment options. Twenty-eight patients received an intravenous (IV) infusion of FA 100 mg/m(2) over 1 hour and a 5-FU 450 mg/m(2) IV bolus in the middle of the FA infusion. After the FA infusion, gemcitabine was administered at a steady rate of infusion of 10 mg/m(2)/min over initially 30 minutes and with increases of an additional 15 minutes at each given level. One cycle consisted of six weekly treatments followed by a 2-week rest. RESULTS: The MTD of gemcitabine was established at 900 mg/m(2) given over 90 minutes. Eight patients of 21 with metastatic colorectal cancer achieved responses (one complete response; seven partial responses), for a response rate of 38%. Responses were seen across the gemcitabine doses of 300 to 900 mg/m(2). One patient had prior treatment with FA/5-FU for advanced disease. Patients with colorectal carcinoma had a median survival of 18 months, and the patient with lung carcinoma has been alive for 24+ months. CONCLUSION: The combination chemotherapy of FFG was well tolerated and may benefit patients with advanced colorectal carcinoma. A phase II evaluation in this patient population is in progress.
Authors: Stefan Madajewicz; David M Waterhouse; Paul S Ritch; M Qaseem Khan; Donald J Higby; Cynthia G Leichman; Sandeep K Malik; Patricia Hentschel; John F Gill; Luping Zhao; Steven J Nicol Journal: Invest New Drugs Date: 2010-12-01 Impact factor: 3.850
Authors: Sherry Morgan-Meadows; James P Thomas; Daniel Mulkerin; Jordan D Berlin; Howard Bailey; Kim Binger; Jennifer Volkman; Dona Alberti; Chris Feierabend; Rebecca Marrocha; Rhoda Z Arzoomanian; George Wilding Journal: Invest New Drugs Date: 2002-11 Impact factor: 3.850
Authors: P Jiménez-Fonseca; M P Solis; M Garrido; L Faez; D Rodriguez; A L Ruiz; M L Sanchez Lorenzo; E Uriol; M D Menendez; J M Viéitez Journal: Clin Transl Oncol Date: 2014-11-27 Impact factor: 3.405
Authors: P Correale; S Messinese; M Caraglia; S Marsili; A Piccolomini; R Petrioli; F Ceciarini; L Micheli; C Nencini; A Neri; G Vuolo; A Guarnieri; A Abbruzzese; S D Prete; G Giorgi; G Francini Journal: Br J Cancer Date: 2004-05-04 Impact factor: 7.640
Authors: F Di Costanzo; P Carlini; L Doni; B Massidda; R Mattioli; A Iop; E Barletta; L Moscetti; F Recchia; P Tralongo; S Gasperoni Journal: Br J Cancer Date: 2005-07-25 Impact factor: 7.640