Moore, D.H., Donnelly, J., McGuire, W.P., Almadrones, L., Cella, D.F., Herzog, T.J., & Waggoner, S.E. (2003). Limited access trial using amifostine for protection against cisplatin and three hour paclitaxel-induced neurotoxicity: A phase II study of the Gynecologic Oncology Group. Journal of Clinical Oncology, 21(22), 4207–4213.
To determine the proportion of women who experience significant treatment-induced peripheral neuropathy
Women with gynecologic cancer received combination chemotherapy consisting of cisplatin and paclitaxel via IV 175 mg/m2 over three hours, followed by amifostine 740 mg/m2 and cisplatin 75 mg/m2 administered over 90 minutes beginning 15 minutes after amifostine administration.
Four of 27 assessable patients experienced dose-limiting toxicity grade 2 or higher CIPN as measured by clinical assessment and NCI CTCAE grading. The number of neuropathic events exceeded the predetermined threshold level for a second stage of accrual and the study was closed.
Amifostine’s level of activity was insufficient to warrant further study in a phase III trial.