RT Journal Article
SR Electronic
T1 Phase II study of tirapazamine plus cisplatin in patients with advanced or recurrent cervical cancer
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP 1165
OP 1171
DO 10.1136/ijgc-00009577-200605000-00033
VO 16
IS 3
A1 F. C. Maluf
A1 A. L. Leiser
A1 C. Aghajanian
A1 P. Sabbatini
A1 S. Pezzulli
A1 D. S. Chi
A1 J. K. Wolf
A1 C. Levenback
A1 E. Loh
A1 D. R. Spriggs
YR 2006
UL http://ijgc.bmj.com/content/16/3/1165.abstract
AB The aim of this study was to evaluate the activity and toxicity of a tirapazamine (TPZ)/cisplatin drug combination in patients with stage IV or recurrent cervical cancer. The chemotherapy was administered for a maximum of eight cycles every 21 days. TPZ was administered intravenously at 330 mg/m2 over a 2-h infusion, followed 1 h later by cisplatin intravenously at 75 mg/m2 over 1 h on day 1. All patients received antiemetics including dexamethasone, ondansetron, and lorazepam. Subsequent doses were unchanged, reduced, or omitted according to observed toxicity and protocol guidelines. Response evaluation was performed every two cycles. Thirty-six patients with stage IV or recurrent cervical cancer were treated. Ninety-four percent of patients had prior radiotherapy. Two patients had prior chemotherapy. There were two complete responses and eight partial responses (27.8%). An additional 11 patients (30.6%) had stable disease as their best response. Response rate was greater in tumors outside of the previously radiated field (44.4% vs 11.1%). The median time to progression was 32.7 weeks. The most frequent grade 3 or 4 adverse events were nausea, vomiting, and fatigue, which occurred in 30.6%, 25%, and 22% of subjects, respectively. Anemia was the most frequent grade 3 or 4 hematologic toxicity at 8.3%. We conclude that the combination of cisplatin and TPZ was reasonably well tolerated in patients with recurrent or advanced cervical cancer. Further evaluation of this drug combination may be warranted.