Phase II of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer, previously treated with platinum and taxanes.
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.
Pecorelli
S
S
Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.
Ray-Coquard
I
I
Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
Tredan
O
O
Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
Colombo
N
N
Medical Gynecologic Oncology Unit, European Institute of Oncology, University of Milan Bicocca, Milan, Italy.
Parma
G
G
Medical Gynecologic Oncology Unit, European Institute of Oncology, University of Milan Bicocca, Milan, Italy.
Tisi
G
G
Department of Obstetrics and Gynecology, University of Brescia, Brescia, Italy.
Katsaròs
D
D
Gynecologic Oncology Unit, University of Turin, Turin, Italy.
Lhommé
C
C
Department of Medical Gynaecology-Oncology, Institut Gustave Roussy, Villejuif, France.
Lissoni
A A
AA
Gynecologic Oncology Unit, San Gerardo Hospital, University of Milan Bicocca, Monza, Italy.
Vermorken
J B
JB
Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium.
du Bois
A
A
Department of Gynecology and Gynecologic Oncology, Dr Horst Schmidt Klinik (HSK), Wiesbaden, Germany.
Poveda
A
A
Onco Gynecological Area, Fundación Instituto Valenciano de Oncología, Valencia, Spain.
Frigerio
L
L
Department of Obstetrics and Gynecology, Ospedali Riuniti, Bergamo, Italy.
Barbieri
P
P
sigma-tau Research Switzerland S.A., Mendrisio, Switzerland. Electronic address: paola.barbieri@st-research.ch.
Carminati
P
P
sigma-tau Industrie Farmaceutiche Riunite S.p.A., Pomezia (Roma), Italy.
Brienza
S
S
Debioclinic S.A., Charenton le Pont, France.
Guastalla
J P
JP
Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
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
D000970:Antineoplastic Agents; C433984:ST 1481; D043823:Taxoids; D010984:Platinum; D002166:Camptothecin