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.
dc.contributor.author | Clamp, Andrew R | |
dc.contributor.author | Adams, M | |
dc.contributor.author | Atkinson, Ronnie | |
dc.contributor.author | Boven, E | |
dc.contributor.author | Calvert, A Hilary | |
dc.contributor.author | Cervantes, A | |
dc.contributor.author | Ganesan, T S | |
dc.contributor.author | Lotz, J | |
dc.contributor.author | Vasey, P | |
dc.contributor.author | Cheverton, P | |
dc.contributor.author | Jayson, Gordon C | |
dc.date.accessioned | 2009-08-20T10:28:30Z | |
dc.date.available | 2009-08-20T10:28:30Z | |
dc.date.issued | 2004-10 | |
dc.identifier.citation | 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. 2004, 95 (1):114-9 Gynecol. Oncol. | en |
dc.identifier.issn | 0090-8258 | |
dc.identifier.pmid | 15385119 | |
dc.identifier.doi | 10.1016/j.ygyno.2004.06.047 | |
dc.identifier.uri | http://hdl.handle.net/10541/77983 | |
dc.description.abstract | OBJECTIVES: 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. | |
dc.language.iso | en | en |
dc.subject | Ovarian Cancer | en |
dc.subject.mesh | Adult | |
dc.subject.mesh | Aged | |
dc.subject.mesh | Antineoplastic Agents, Phytogenic | |
dc.subject.mesh | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject.mesh | Bridged Compounds | |
dc.subject.mesh | Camptothecin | |
dc.subject.mesh | DNA Topoisomerases, Type I | |
dc.subject.mesh | Drug Administration Schedule | |
dc.subject.mesh | Drug Resistance, Multiple | |
dc.subject.mesh | Drug Resistance, Neoplasm | |
dc.subject.mesh | Enzyme Inhibitors | |
dc.subject.mesh | Female | |
dc.subject.mesh | Humans | |
dc.subject.mesh | Middle Aged | |
dc.subject.mesh | Organoplatinum Compounds | |
dc.subject.mesh | Ovarian Neoplasms | |
dc.subject.mesh | Taxoids | |
dc.title | 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. | en |
dc.type | Article | en |
dc.contributor.department | Cancer Research UK Deparment of Medical Oncology, Christie Hospital, M20 4BX, UK. | en |
dc.identifier.journal | Gynecologic Oncology | en |
html.description.abstract | OBJECTIVES: 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. |