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  • Title: [Phase II clinical study of topotecan hydrochloride in patients with recurrent advanced ovarian cancer].
    Author: Li JD, Guan ZZ, Liu JH, Xin XY, Cui Y, Huang CJ, Liu FY, Song L, Bian ML, Zhou QH.
    Journal: Ai Zheng; 2002 Apr; 21(4):416-20. PubMed ID: 12452024.
    Abstract:
    BACKGROUND AND OBJECTIVE: Clinical studies showed there was no satisfying treatment of the patients with recurrent advanced ovarian cancer by using chemotherapy of combining platinum, and it is very important for oncologist to seek the second-line drugs to treat the patients with recurrent ovarian cancer. The current study was designed to evaluate the efficacy and toxicity of single agent Topotecan hydrochloride in the patients with recurrent advanced ovarian cancer. MATERIAL AND METHOD: A total of 31 patients with recurrent ovarian cancer in a multiple centers clinical trial were treated with Topotecan 1.25 mg/m2 qd, i.v. inf. for 5 consecutive days every three weeks. RESULT: Among 21 evaluable cases, overall response rate was 33.33%. Among 29 ITT population the response rate was 24.14%, including 3 CR and 4 PR. Main side effects were hematologic toxicities, 31.0% patients and 37.5% courses developed Grade III-IV leukocytopenia, 20.7% patients and 14.3% courses developed Grade III-IV thrombocytopemia. Non-hematologic toxicities were mild. CONCLUSION: Topotecan is effective for treating the patients with recurrent ovarian cancer who failed with platinum-based regimes.
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