A phase II clinical trial of topotecan in Japanese patients with relapsed ovarian carcinoma.
OBJECTIVE
This Phase II study was carried out to investigate the efficacy, safety and pharmacokinetics of topotecan in Japanese patients with relapsed ovarian carcinoma.


METHODS
Patients with relapsed ovarian carcinoma after having received one regimen containing platinum-based chemotherapy were eligible for this study. Topotecan was administered at 1.2 mg/m(2)/day for five consecutive days, repeated every 3 weeks.


RESULTS
Seventy-two patients were enrolled in the study. The response rate was 28.2% (95% confidence interval, 18.1-40.1%). Signs of myelosuppression, such as neutropenia (Grade 3, 12.5%; Grade 4, 83.3%), thrombocytopenia (Grade 3, 36.2%; Grade 4, 4.2%) and decreased hemoglobin (Grade 3, 36.1%; Grade 4, 11.1%), were the most common hematological toxicities. Grade 3 febrile neutropenia occurred in 5 (6.9%) patients. There was little intraindividual or interindividual variability in the pharmacokinetics of topotecan.


CONCLUSIONS
Topotecan at 1.2 mg/m(2)/day is an effective and tolerable therapeutic option for Japanese patients with relapsed ovarian carcinoma.
Aoki
Daisuke
D
Department of Obstetrics and Gynecology, School of Medicine, Keio University, Shinjuku-ku, Tokyo 160-8582, Japan. aoki@sc.itc.keio.ac.jp
Katsumata
Noriyuki
N
Nakanishi
Toru
T
Kigawa
Junzo
J
Fujiwara
Keiichi
K
Takehara
Kazuhiro
K
Kamiura
Shoji
S
Hiura
Masamichi
M
Hatae
Masayuki
M
Sugiyama
Toru
T
Ochiai
Kazunori
K
Noda
Kiichiro
K
D018262:Adenocarcinoma, Clear Cell / Q000188:drug therapy* / Q000473:pathology; D002288:Adenocarcinoma, Mucinous / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy* / Q000473:pathology; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011379:Prognosis; D016879:Salvage Therapy; D015996:Survival Rate; D014018:Tissue Distribution; D059004:Topoisomerase I Inhibitors / Q000493:pharmacokinetics / Q000627:therapeutic use; D019772:Topotecan / Q000493:pharmacokinetics / Q000627:therapeutic use*
D059004:Topoisomerase I Inhibitors; D019772:Topotecan