title: Phase II of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer, previously treated with platinum and taxanes.
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.
  
  
  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.
  
  
  CONCLUSIONS
  Gimatecan is a new active agent in previously treated ovarian cancer with myelosuppression as main toxicity.
authors.affiliation: Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Pecorelli
authors.affiliation: Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
authors.forename: I
authors.initials: I
authors.lastname: Ray-Coquard
authors.affiliation: Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
authors.forename: O
authors.initials: O
authors.lastname: Tredan
authors.affiliation: Medical Gynecologic Oncology Unit, European Institute of Oncology, University of Milan Bicocca, Milan, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Colombo
authors.affiliation: Medical Gynecologic Oncology Unit, European Institute of Oncology, University of Milan Bicocca, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Parma
authors.affiliation: Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Tisi
authors.affiliation: Gynecologic Oncology Unit, University of Turin, Turin, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Katsaròs
authors.affiliation: Department of Medical Gynaecology-Oncology, Institut Gustave Roussy, Villejuif, France.
authors.forename: C
authors.initials: C
authors.lastname: Lhommé
authors.affiliation: Gynecologic Oncology Unit, San Gerardo Hospital, University of Milan Bicocca, Monza, Italy.
authors.forename: A A
authors.initials: AA
authors.lastname: Lissoni
authors.affiliation: Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium.
authors.forename: J B
authors.initials: JB
authors.lastname: Vermorken
authors.affiliation: Department of Gynecology and Gynecologic Oncology, Dr Horst Schmidt Klinik (HSK), Wiesbaden, Germany.
authors.forename: A
authors.initials: A
authors.lastname: du Bois
authors.affiliation: Onco Gynecological Area, Fundación Instituto Valenciano de Oncología, Valencia, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Poveda
authors.affiliation: Department of Obstetrics and Gynecology, Ospedali Riuniti, Bergamo, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Frigerio
authors.affiliation: sigma-tau Research Switzerland S.A., Mendrisio, Switzerland. Electronic address: paola.barbieri@st-research.ch.
authors.forename: P
authors.initials: P
authors.lastname: Barbieri
authors.affiliation: sigma-tau Industrie Farmaceutiche Riunite S.p.A., Pomezia (Roma), Italy.
authors.forename: P
authors.initials: P
authors.lastname: Carminati
authors.affiliation: Debioclinic S.A., Charenton le Pont, France.
authors.forename: S
authors.initials: S
authors.lastname: Brienza
authors.affiliation: Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
authors.forename: J P
authors.initials: JP
authors.lastname: Guastalla
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017024:Chemotherapy, Adjuvant; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000473:pathology; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010984:Platinum / Q000008:administration & dosage; D012008:Recurrence; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D000970:Antineoplastic Agents; C433984:ST 1481; D043823:Taxoids; D010984:Platinum; D002166:Camptothecin