BACKGROUND: The objective of the present clinical study is to determine the maximum tolerated dose (MTD)/recommended dose (RD) of combination therapy with nanoparticle albumin-bound paclitaxel (nab-PTX) and cyclophosphamide (CPA) in patients with metastatic or recurrent breast cancer. METHODS: nab-PTX and CPA were administered on the first day of each 21-day treatment cycle. The dose of CPA was fixed at 600 mg/m(2), while the dose of nab-PTX was increased from 180 mg/m(2) (Level 1) to 220 mg/m(2) (Level 2) and then to 260 mg/m(2) (Level 3). RESULTS: A total of 11 patients from two institutions were enrolled in the present study. At Level 3, a dose-limiting toxicity (DLT) was observed in 1 patient. Considering treatment continuity and the risk of adverse events in Cycle 2 and thereafter at this level, further subject enrollment at Level 3 was discontinued after two patients had been enrolled. Since the doses used at Level 3 were considered the MTD of nab-PTX and CPA and the doses used at Level 2 were considered the RD of nab-PTX and CPA, three additional subjects were enrolled at Level 2. No DLTs were observed at Level 2. CONCLUSION: The RD of combination therapy with nab-PTX and CPA was 220 mg/m(2) and 600 mg/m(2), respectively, in patients with metastatic or recurrent breast cancer.
BACKGROUND: The objective of the present clinical study is to determine the maximum tolerated dose (MTD)/recommended dose (RD) of combination therapy with nanoparticle albumin-bound paclitaxel (nab-PTX) and cyclophosphamide (CPA) in patients with metastatic or recurrent breast cancer. METHODS:nab-PTX and CPA were administered on the first day of each 21-day treatment cycle. The dose of CPA was fixed at 600 mg/m(2), while the dose of nab-PTX was increased from 180 mg/m(2) (Level 1) to 220 mg/m(2) (Level 2) and then to 260 mg/m(2) (Level 3). RESULTS: A total of 11 patients from two institutions were enrolled in the present study. At Level 3, a dose-limiting toxicity (DLT) was observed in 1 patient. Considering treatment continuity and the risk of adverse events in Cycle 2 and thereafter at this level, further subject enrollment at Level 3 was discontinued after two patients had been enrolled. Since the doses used at Level 3 were considered the MTD of nab-PTX and CPA and the doses used at Level 2 were considered the RD of nab-PTX and CPA, three additional subjects were enrolled at Level 2. No DLTs were observed at Level 2. CONCLUSION: The RD of combination therapy with nab-PTX and CPA was 220 mg/m(2) and 600 mg/m(2), respectively, in patients with metastatic or recurrent breast cancer.
Authors: Theresa A John; Stephen M Vogel; Chinnaswamy Tiruppathi; Asrar B Malik; Richard D Minshall Journal: Am J Physiol Lung Cell Mol Physiol Date: 2003-01 Impact factor: 5.464
Authors: Nuhad K Ibrahim; Neil Desai; Sewa Legha; Patrick Soon-Shiong; Richard L Theriault; Edgardo Rivera; Bita Esmaeli; Sigrid E Ring; Agop Bedikian; Gabriel N Hortobagyi; Julie A Ellerhorst Journal: Clin Cancer Res Date: 2002-05 Impact factor: 12.531
Authors: Nuhad K Ibrahim; Brian Samuels; Ray Page; Dinesh Doval; Kirtikumar M Patel; S C Rao; Madhavan Krishnan Nair; Paul Bhar; Neil Desai; Gabriel N Hortobagyi Journal: J Clin Oncol Date: 2005-09-01 Impact factor: 44.544
Authors: Denise Yardley; Howard Burris; Nancy Peacock; Eric Raefsky; Marianne Melnik; Roger Inhorn; Dianna Shipley; John Hainsworth Journal: Breast Cancer Res Treat Date: 2010-07-24 Impact factor: 4.872
Authors: Stephen E Jones; Michael A Savin; Frankie Ann Holmes; Joyce A O'Shaughnessy; Joanne L Blum; Svetislava Vukelja; Kristi J McIntyre; John E Pippen; James H Bordelon; Robert Kirby; John Sandbach; William J Hyman; Pankaj Khandelwal; Angel G Negron; Donald A Richards; Stephen P Anthony; Robert G Mennel; Kristi A Boehm; Walter G Meyer; Lina Asmar Journal: J Clin Oncol Date: 2006-12-01 Impact factor: 44.544
Authors: D D Von Hoff; M W Layard; P Basa; H L Davis; A L Von Hoff; M Rozencweig; F M Muggia Journal: Ann Intern Med Date: 1979-11 Impact factor: 25.391
Authors: Jonathan C Trent; Vicente Valero; Daniel J Booser; Laura T Esparza-Guerra; Nuhad Ibrahim; Zia Rahman; Laurent Vernillet; Shreyaskumar Patel; Cynthia L David; James L Murray; Massimo Cristofanilli; Gabriel N Hortobagyi Journal: Clin Cancer Res Date: 2003-07 Impact factor: 12.531