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.

2.50
Hdl Handle:
http://hdl.handle.net/10541/77983
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.
Authors:
Clamp, Andrew R; Adams, M; Atkinson, Ronnie; Boven, E; Calvert, A Hilary; Cervantes, A; Ganesan, T S; Lotz, J; Vasey, P; Cheverton, P; Jayson, Gordon C ( 0000-0002-8515-8944 )
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.
Affiliation:
Cancer Research UK Deparment of Medical Oncology, Christie Hospital, M20 4BX, UK.
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.
Journal:
Gynecologic Oncology
Issue Date:
Oct-2004
URI:
http://hdl.handle.net/10541/77983
DOI:
10.1016/j.ygyno.2004.06.047
PubMed ID:
15385119
Type:
Article
Language:
en
ISSN:
0090-8258
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorClamp, Andrew R-
dc.contributor.authorAdams, M-
dc.contributor.authorAtkinson, Ronnie-
dc.contributor.authorBoven, E-
dc.contributor.authorCalvert, A Hilary-
dc.contributor.authorCervantes, A-
dc.contributor.authorGanesan, T S-
dc.contributor.authorLotz, J-
dc.contributor.authorVasey, P-
dc.contributor.authorCheverton, P-
dc.contributor.authorJayson, Gordon C-
dc.date.accessioned2009-08-20T10:28:30Z-
dc.date.available2009-08-20T10:28:30Z-
dc.date.issued2004-10-
dc.identifier.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.en
dc.identifier.issn0090-8258-
dc.identifier.pmid15385119-
dc.identifier.doi10.1016/j.ygyno.2004.06.047-
dc.identifier.urihttp://hdl.handle.net/10541/77983-
dc.description.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.en
dc.language.isoenen
dc.subjectOvarian Canceren
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntineoplastic Agents, Phytogenic-
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshBridged Compounds-
dc.subject.meshCamptothecin-
dc.subject.meshDNA Topoisomerases, Type I-
dc.subject.meshDrug Administration Schedule-
dc.subject.meshDrug Resistance, Multiple-
dc.subject.meshDrug Resistance, Neoplasm-
dc.subject.meshEnzyme Inhibitors-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshMiddle Aged-
dc.subject.meshOrganoplatinum Compounds-
dc.subject.meshOvarian Neoplasms-
dc.subject.meshTaxoids-
dc.titleA 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.typeArticleen
dc.contributor.departmentCancer Research UK Deparment of Medical Oncology, Christie Hospital, M20 4BX, UK.en
dc.identifier.journalGynecologic Oncologyen

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