A phase II clinical trial of topotecan in Japanese patients with relapsed ovarian carcinoma

Daisuke Aoki, Noriyuki Katsumata, Toru Nakanishi, Junzo Kigawa, Keiichi Fujiwara, Kazuhiro Takehara, Shoji Kamiura, Masamichi Hiura, Masayuki Hatae, Toru Sugiyama, Kazunori Ochiai, Kiichiro Noda

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Abstract

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/m2/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/m2/day is an effective and tolerable therapeutic option for Japanese patients with relapsed ovarian carcinoma.

Original languageEnglish
Article numberhyq192
Pages (from-to)320-327
Number of pages8
JournalJapanese journal of clinical oncology
Volume41
Issue number3
DOIs
Publication statusPublished - 2011 Mar 1

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Keywords

  • Clinical trial
  • Pharmacokinetics
  • Phase II
  • Relapsed ovarian carcinoma
  • Topotecan

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Aoki, D., Katsumata, N., Nakanishi, T., Kigawa, J., Fujiwara, K., Takehara, K., Kamiura, S., Hiura, M., Hatae, M., Sugiyama, T., Ochiai, K., & Noda, K. (2011). A phase II clinical trial of topotecan in Japanese patients with relapsed ovarian carcinoma. Japanese journal of clinical oncology, 41(3), 320-327. [hyq192]. https://doi.org/10.1093/jjco/hyq192