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

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/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.

• Authors: Daisuke Aoki, Noriyuki Katsumata, Toru Nakanishi, Junzo Kigawa, Keiichi Fujiwara, Kazuhiro Takehara, Shoji Kamiura, Masamichi Hiura, Masayuki Hatae, Toru Sugiyama, Kazunori Ochiai, Kiichiro Noda
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 41 Issue 3 Pg. 320-7 (Mar 2011) ISSN: 1465-3621 [Electronic] England
• PMID: 20974678 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Topoisomerase I Inhibitors
• Topotecan

Topics

• Adenocarcinoma, Clear Cell (drug therapy, pathology)
• Adenocarcinoma, Mucinous (drug therapy, pathology)
• Adult
• Aged
• Cohort Studies
• Cystadenocarcinoma, Serous (drug therapy, pathology)
• Endometrial Neoplasms (drug therapy, pathology)
• Female
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Neoplasm Staging
• Ovarian Neoplasms (drug therapy, pathology)
• Prognosis
• Salvage Therapy
• Survival Rate
• Tissue Distribution
• Topoisomerase I Inhibitors (pharmacokinetics, therapeutic use)
• Topotecan (pharmacokinetics, therapeutic use)