Phase II of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer, previously treated with platinum and taxanes.

TitlePhase II of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer, previously treated with platinum and taxanes.
Publication TypeJournal Article
Year of Publication2010
AuthorsPecorelli, S, Ray-Coquard, I, Tredan, O, Colombo, N, Parma, G, Tisi, G, Katsaros, D, Lhommé, C, Lissoni, A, Vermorken, JB, du Bois, A, Poveda, AM, Frigerio, L, Barbieri, P, Carminati, P, Brienza, S, Guastalla, JP
JournalAnn Oncol
Volume21
Issue4
Pagination759-65
Date Published2010 Apr
ISSN1569-8041
KeywordsAdministration, Oral, Adult, Aged, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Chemotherapy, Adjuvant, Fallopian Tube Neoplasms, Female, Humans, Middle Aged, Neoplasms, Glandular and Epithelial, Ovarian Neoplasms, Peritoneal Neoplasms, Platinum, Recurrence, Taxoids
Abstract

BACKGROUND: A prospective phase II study was conducted to evaluate the efficacy and toxicity of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer.PATIENTS AND METHODS: Patients had a maximum of three prior chemotherapy lines with no more than two prior platinum-containing regimens and a progression-free interval after the last dose of platinum <12 months. A total dose of 4 mg/m(2)/cycle (0.8 mg/m(2)/day from day 1 to day 5) was administered, repeated every 28 days.RESULTS: From June 2005 to December 2005, 69 assessable patients were enrolled. The best overall response to study treatment by combined CA-125 and RECIST criteria was partial response in 17 patients (24.6%) and disease stabilization in 22 patients (31.9%). The median time to progression and overall survival were 3.8 and 16.2 months, respectively. A total of 312 cycles were administered. Neutropenia grade 4 and thrombocytopenia grade 4 occurred in 17.4% and 7.2% of patients, respectively. Diarrhea grade 4 was never observed. Asthenia and fatigue were reported by 36.2% and 18.8% of patients, but were all grade 2 or less.CONCLUSION: Gimatecan is a new active agent in previously treated ovarian cancer with myelosuppression as main toxicity.

DOI10.1093/annonc/mdp514
Alternate JournalAnn. Oncol.
PubMed ID19906760
PubMed Central IDPMC2844948