A phase IIA study of the topoisomerase I inhibitor, exatecan mesylate (DX-8951f), administered at two different dose schedules in patients with platinum- and taxane-resistant/refractory ovarian cancer.
AuthorsClamp, Andrew R
Calvert, A Hilary
Ganesan, T S
Jayson, Gordon C
AffiliationCancer Research UK Deparment of Medical Oncology, Christie Hospital, M20 4BX, UK.
MetadataShow full item record
AbstractOBJECTIVES: There is an urgent need for new agents with activity in platinum- and taxane-resistant epithelial ovarian cancer. Exatecan mesylate is a novel topoisomerase I inhibitor with potent activity against ovarian cancer in vitro. A multicentre phase IIA study was conducted in patients with platinum- and taxane-resistant epithelial ovarian cancer. PATIENTS AND METHODS: Fifty-seven patients with bidimensionally measurable ovarian cancer, previously exposed to platinum and taxanes, whose disease had relapsed within 6 months of platinum-containing chemotherapy were randomised to one of two intravenous schedules of exatecan mesylate; 0.3 mg/m(2) daily for 5 days every 3 weeks (Arm A) or 2.1 mg/m(2) weekly for 3 weeks out of 4 (Arm B). RESULTS: There were no responses in the weekly arm and a radiological response rate of 5.3% (95% CI 0.3-21.8%) in the daily arm. Principal toxicities were myelosuppression and emesis. Grade 3/4 neutropenia occurred in 29% of patients in Arm A and 6% patients in Arm B. Seventy-one percent of patients in Arm A required red cell transfusions while on treatment. CONCLUSIONS: Exatecan is well tolerated in this poor prognosis group of patients but only has modest single agent activity when administered in a daily regimen.
CitationA phase IIA study of the topoisomerase I inhibitor, exatecan mesylate (DX-8951f), administered at two different dose schedules in patients with platinum- and taxane-resistant/refractory ovarian cancer. 2004, 95 (1):114-9 Gynecol. Oncol.
- A phase II study of intravenous exatecan mesylate (DX-8951f) administered daily for 5 days every 3 weeks to patients with advanced ovarian, tubal or peritoneal cancer resistant to platinum, taxane and topotecan.
- Authors: Verschraegen CF, Kudelka AP, Hu W, Vincent M, Kavanagh JJ, Loyer E, Bastien L, Duggal A, De Jager R
- Issue date: 2004 Jan
- A Phase II study of intravenous exatecan mesylate (DX-8951f) administered daily for 5 days every 3 weeks to patients with metastatic breast carcinoma.
- Authors: Esteva FJ, Rivera E, Cristofanilli M, Valero V, Royce M, Duggal A, Colucci P, DeJager R, Hortobagyi GN
- Issue date: 2003 Sep 1
- Phase I study of topoisomerase I inhibitor exatecan mesylate (DX-8951f) given as weekly 24-hour infusions three of every four weeks.
- Authors: Sharma S, Kemeny N, Schwartz GK, Kelsen D, O'Reilly E, Ilson D, Coyle J, De Jager RL, Ducharme MP, Kleban S, Hollywood E, Saltz LB
- Issue date: 2001 Dec
- Phase II evaluation of CKD-602, a camptothecin analog, administered on a 5-day schedule to patients with platinum-sensitive or -resistant ovarian cancer.
- Authors: Lee HP, Seo SS, Ryu SY, Kim JH, Bang YJ, Park SY, Nam JH, Kang SB, Lee KH, Song YS
- Issue date: 2008 Jun
- Phase I and pharmacokinetic study of the topoisomerase I inhibitor, exatecan mesylate (DX-8951f), using a weekly 30-minute intravenous infusion, in patients with advanced solid malignancies.
- Authors: Braybrooke JP, Boven E, Bates NP, Ruijter R, Dobbs N, Cheverton PD, Pinedo HM, Talbot DC
- Issue date: 2003 Jun